APIs And Intermediates

Pharma Intermediate Pregnenolone

Appearance: White-like crystalline powder; Melting range: 180.0ï 193.0ï; Loss on drying: Not more than 0.40%; Assay: Not less than 99.0%; Specific optical rotation: +25.5 +31.5; Total impurities: Not more than 1.00%; Any single impurity: Not more than 0.50%

Cefazolin Sodium Sterile

Appearance: White or almost white powder, very hygroscopic; Solubility: Freely soluble in water, very slightly soluble in ethanol (96 per cent); Specific Optical Rotation: -24 -15; Appearance of Solution: Clear Absorbance: Not more than 0.15 (430nm); pH Value: 4.0 6.0; Absorbance: 260 300; Any impurity: Not more than 1.0%; Total impurities: Not more than 3.5%; N,N-dimethylaniline: Not more than 0.0020%; Water: Not more than 6.0%; Bacterial endotoxins: Less than 0.15 IU/mg; Sterility: Sterile; Dichloromethane (in-house): Not more than 0.06%; Acetone (in-house): Not more than 0.5%; Ethanol (in-house): Not more than 0.5%; Acetic Acid (in-house): Not more than 0.5%; Dimethyl carbonate (in-house): Not more than 0.5%; Triethylamine (in-house): Not more than 0.02%; Visible Particles (in-house): Meet the requirements; Assay: 95.0% 102.0% of C14H13N8NaO4S3 (anhydrous substance)

Creatine Pyruvate

Description: White or off-white crystalline powder; Loss on Drying: Not more than 0.5%; Heavy Metals: Not more than 10ppm; Arsenic(As): Not more than 1ppm; Iron(Fe): Not more than 10ppm; Pyruvic Radical: Not less than 30.0%; Creatine: Not less than 58.0%

Eptifibatide Acetate

Characteristic: This product is a white or off-white amorphous powder; odourless and hygroscopic. It is easily soluble in water and almost insoluble in chloroform or acetone; Specific Rotation: Calculated based on anhydrous and acetic acid-free product, the specific rotation is between -52.0 and -56.0; Solution Clarity and Colour: The solution should be clear and colourless. If it is turbid, it should not be darker than the No. 2 turbidity standard solution; if it is coloured, it should not be darker than the yellow No. 1 or yellow-green No. 1 standard colorimetric solution; Acidity: The pH value should be between 3.5 and 5.5; Moisture: Not more than 5.0%; Acetic Acid: Not more than 12.0%; Trifluoroacetic Acid: Not more than 0.5%; Methanol: Not more than 0.3%; Acetonitrile: Not more than 0.041%; N,N-Dimethylformamide: Not more than 0.088%; Asparatic Acid (Asp): 0.8 1.2; Homoarginine (H-HomoArg-OH): 0.8 1.2; Glycine (Gly): 0.8 1.2; Proline (Pro): 0.8 1.2; Tryptophan (Trp): 0.8 1.2; Cysteine (Cys): 0.8 1.2; Related Substances: The peak area of impurity A and impurity H shall not be greater than 1.5 times (0.3%) of the main peak area of the control solution. The peak area of impurity B, impurity C, impurity D and impurity E multiplied by the correction factor (correction factor 1.23), impurity F (correction factor 0.86) and impurity G (correction factor 1.24) shall not be greater than the main peak area of the control solution (0.2%); The peak area of other single unknown impurities shall not be greater than the main peak area of the control solution (0.2%), and the sum of the peak areas of each impurity shall not be greater than 5 times the main peak area of the control solution (1.0%); Polymer: The retention time of each component less than that of eptifibatide impurity G must not exceed 0.5%, and the total impurities should not exceed 1.0% (including impurity G); Arsenic salt: Not more than 0.00015%; Bacterial endotoxins: The amount of endotoxin contained in every 1 mg of eptifibatide should be less than 0.2 EU; Total Aerobic Microbial Count: Not more than 1000 CFU/g; Total Yeasts and Moulds Count: Not more than 100 CFU/g; Bile-tolerant Gram-negative Bacteria; Assay: Calculated as anhydrous and acetic acid-free, this product contains eptifibatide 98.0% 102.0%

2-Methyl-2-Propanesulfinamide C4H11NOS

Appearance: White to off-white solid; Purity (LC-220nm): Not less than 99%; E.E.: Not more than 10%; Water Content (KF): Not more than 0.5%; HNMR: Conforms; Solubility (ACN): Not less than 10 mg/mL (Clear solution)

Vosoritide Acetate

Appearance: White or off-white powder; Molecular Ion Mass: 4102.78; Purity (HPLC): Not less than 95.0%

Bis(Pinacolato)Diboron C12H24B2O4

Appearance: White to off-white solid; Purity (GC): Not less than 99%; Melting Point: 135ï 145ï, melting range: ï3ï; Water Content (KF): Not more than 0.3%

2-Bromopropene C3H5Br

Appearance: Colourless to yellow liquid; Purity (GC): Not less than 99%; Inhibition (BHT GC Area%): Not more than 1%; Water Content (KF): Not more than 0.1%; HNMR: Conforms

(S)-(-)-2-Methyl-2-Propanesulfinamide C4H11NOS

Appearance: White to off-white solid; Purity (LC-220nm): Not less than 99%; E.E.: Not less than 99%; Water Content (KF): Not more than 0.5%; HNMR: Conforms; Solubility (ACN): Not less than 10 mg/mL(Clear solution)

GIPGLP 1 Tirzepatide

Appearance: White or almost white powder; Molecular Ion Mass: 4813.45; Purity(HPLC): Not less than 98.0%; Total impurities: Not more than 2.0%; Maximum single impurity: Not more than 1.0%; Acetic Acid Content(HPLC) Not more than 15.0%; TFA Content(HPLC): Not more than 1.0%; Sodium Ion(IC): Reported value; Water Content(K. F): Not more than 8.0%; pH Value: 7.0 9.0; Solubility: Reported value; Oligomer: Not more than 3.0%; TAMC: Not more than 500 CFU/g; TYMC: Not more than 500 CFU/g

(R)-(+)-2-Methyl-2-Propanesulfinamide C4H11NOS

Appearance: White to off-white solid; Purity (LC-220nm): Not less than 99.0%; E.E.: Not less than 99.0%; Water Content (KF): Not more than 0.5%; HNMR: Conforms; Solubility (Acetonitrile): Not less than 10 mg/mL (Clear liquid)

Isopropoxyboronic Acid Pinacol Ester

Appearance: Colourless to pale yellow liquid; Purity (GC): Not less than 98%; Water Content (KF): Not more than 0.5%

Tetrahydroxydiboron B2H4O4

Appearance: White to off-white solid; Purity (LC-210nm): Not less than 98%; HNMR: Not less than 97%

Phenothiazine C12H9NS

Appearance: Pale yellow powder or flake; Melting Point: 183ï 186ï; Content: Not less than 99.00%; Loss on Drying: Not more than 0.3%; Residue on Ignition: Not more than 0.1%

5-Aminolevulinic Acid Hydrochloride

Appearance: White or almost white powder; Identification: 1) The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. 2) Consistent with the IR spectrum of the Standard. 3) Meets the requirements of Chloride; pH Value: 2.5 2.9; Loss on Drying: Not more than 0.5%; Residue on Ignition: Not more than 0.3%; Assay: Aminolevulinic Acid Hydrochloride contains NLT 98.0% and NMT 102.0% (Calculated on the anhydrous basis); Aminolevulinic acid related compound A: Not more than 0.15%; Aminolevulinic acid related compound B: Not more than 0.15%; Any individual unspecified impurity: Not more than 0.10%; Any other total impurities: Not more than 0.5%; Acetic acid: Not more than 5000ppm; Acetone: Not more than 5000ppm; N-heptane: Not more than 5000ppm; Ethyl acetate: Not more than 5000ppm; Tetrahydrofuran: Not more than 720ppm

Maduramicin Ammonium

Description: White or off-white crystalline powder; slightly odorous; Identification: (1) The retention time of the main peak of the test solution should be the same as that of the standard solution. (2) This product should show the reaction of identifying ammonium salt. Loss on Drying: Not more than 1.8%; Residue on Ignition: Not more than 2.0% Heavy Metals: Not more than 0.002% Assay Maduramicin: Contains Maduramicin not less than 90.0%(on the anhydrous basis)

Molnupiravir C13H19N3O7

Appearance: White to off-white powder; Solubility: This product is freely soluble in dimethyl sulfoxide or methanol, soluble in water, sparingly soluble in ethanol, and practically insoluble in dichloromethane or N-heptane.; Identification: Should be accordance with reference; Water: Not more than 1.0%; Acetone: Not more than 0.5%; Isopropanol: Not more than 0.5%; Tetrahydrofuran: Not more than 0.072%; Triethylamine: Not more than 0.5%; Acetonitrile: Not more than 0.041%; Isobutyric Acid: Not more than 0.5%; Ethyl acetate: Not more than 0.5%; Heptane: Not more than 0.5%; Formic Acid: Not more than 0.5%; Residue on Ignition: Not more than 0.2%; Heavy Metals: Not more than 20 ppm; Impurity A: Not more than 0.1%; Impurity B: Not more than 0.1%; Impurity C: Not more than 0.1%; Impurity D: Not more than 0.1%; Impurity E: Not more than 0.1%; Other impurities: Not more than 0.1%; Sum impurities: Not more than 0.5%; Assay: 98.0% 102.0%

Minocycline Hydrochloride

Appearance: Yellow crystalline powder; Identification-IR: Corresponds to the reference; Identification-Chlorides: Be Positive; Appearance of Solution: Clear, A450nm NMT 0.23; pH Value 3.5 4.5; Light-absorbing impurities: A560nm NMT 0.06; Water: 5.0% 8.0%; Sulfated Ash: Not more than 0.5%; Assay(Calculated on the anhydrous basis): 94.5% 102.0%; Impurity A: Not more than 1.2%; Impurity B: Not more than 0.8%; Impurity C: Not more than 0.6%; Impurity D: Not more than 0.15%; Impurity E: Not more than 0.6%; Impurity F: Not more than 0.5%; Impurity G: Not more than 0.5%; Impurity H: Not more than 0.3%; Total impurities: Not more than 3.5%; Any other impurity: Not more than 0.10%; Impurity I: Not more than 0.15%; RRTïï0.16: Not more than 0.20%; Residual Solvents (Ethanol): Not more than 5000 ppm; Bacterial endotoxins: Less than 1.25 IU/mg; Total aerobic microbial count: Not more than 1000 CFU/g; Total yeasts and moulds count: Not more than 100 CFU/g

O-Phospho-L-Serine H-Ser(PO3H2)-OH

Description: White or off-white crystalline powder; Identification: The location and the colour of the main spot in the test solution should be the same as that in the control solution; Solubility(1% w/v): Complete; pH Value(1% w/v): 1.5 2.5; Transparency(2% w/v 430nm): Not less than 95.0%; Water by KF: Not more than 1.0%; Specific Rotation: +14.0 +16.0; Inorganic Phosphorus: Not more than 0.2%; Sulphate: Not more than 200ppm; Chloride: Not more than 200ppm; Assay(NaOH, Potentiometric): 98.0% 101.0%; L-Serine Content(TLC): Not more than 1%; Each Unknown Impurity(TLC): Not more than 0.1%; Total Impurities(TLC): Not more than 1%; Residual Solvents(Methyl Alcohol): Not more than 1000ppm

Tirzepatide intermediate TBuO-Ara-Glu(AEEA-AEEA-OH)-OtBu

Appearance: Yellowish liquid; Purity: Not less than 90.0%

Tirzepatide side chain Fmoc-Lys(TBuO-Ara-Glu(AEEA-AEEA)-OtBu)-OH

Appearance: Colourless to yellowish viscous liquid; Identity: Meets the requirements; Purity: Not less than 98.0%

2-acetamido-5-sulfamoyl-1 3 4-thiadiazole Acetazolamide

Characteristic: White acicular crystalline or crystalline powder; odourless; Physical and chemical identification 1: Produces a white sediment; Physical and chemical identification 2: Produces a ethyl acetate aroma; Infrared Identification: The infrared absorption spectrum of this product should match with that of the working standard (infrared absorption spectrum 9); pH Value: 4.0 6.0; The clarity of an alkaline solution: The solution should be clarified; Chloride: Not more than 0.014%; Sulphate: Not more than 0.04%; Total impurities: Not more than 1.0%; The single impurity: Not more than 0.5%; Silver reduction: Consumption of ammonium thiocyanate titrates (0.1mol/L) shall not be less than 4.8 ml; Loss on Drying: Not more than 0.5%; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 20 ppm; Assay: 98.0% 102.0% (C4H6N4O3S2); Total aerobic bacteria: Not more than 1000CFU/g; Total molds and yeasts: Not more than 100CFU/g

Semaglutide starting material (S)-2-(2-((tert-Butoxycarbonyl)amino)-3-(1-trityl-1H-imidazol-4-yl)propanamido)-2-methylpropanoic acid

Appearance: White or off-white solid; Identity: Meets the requirements; Purity: Not less than 95.0%

Semaglutide intermediate Fmoc-Lys(tBuO-Ste-Glu(AEEA-AEEA)-OtBu)-OH

Appearance: Colourless to yellowish viscous liquid; Identity: Meets the requirements; Purity: Not less than 95.0%

Semaglutide intermediate tBuO-Ste-Glu(AEEA-AEEA-OSu)-OtBu

Appearance: Yellowish viscous liquid; Identification: Meets the requirements; Molecular Weight: 942.58±0.5 Da; Purity: Not less than 85.0%; e.e. %: Not less than 99.0%; tBuO-Mar-Glu(AEEA-OSu)-OtBu (ZZ-68): Not more than 1.00%; tBuO-Ste-Glu(AEEA-OSu)-OtBu (ZZ-76): Not more than 1.00%; tBuO-Mar-Glu(AEEA-AEEA-OH)-OtBu (ZZ-18): Not more than 1.00%; tBuO-Ste-Glu(AEEA-AEEA-OMe)-OtBu (ZZ-61): Not more than 1.00%; tBuO-Ste-Glu(AEEA-AEEA-OH)-OtBu (ZZ-8): Not more than 5.00%; NHS: Not more than 5.00%; tBuO-Ste-Glu(AEEA-AEEA-OSu)-OtBu-ZZ-82: Not more than 3.00%; DCU: Not more than 3.00%; Moisture: Not more than 2.00%; Dichloromethane: Not more than 30000 ppm; Methyl alcohol: Not more than 3000 ppm; N-heptane: Not more than 5000 ppm; Isopropyl alcohol: Not more than 5000 ppm; Ethyl acetate: Not more than 5000 ppm; Endotoxins: Not more than 2.0 EU/mg

Ferric Carboxymaltose

Description: Red-brown powder; Identification A (Iron): Positive; Identification B(Dextrin): Meets the requirements; pH Value: 5.0 7.0; Loss on Drying: Not more than 10.0%; Content of Chloride: Not more than 6.0%; Limit of Iron (2+): Not more than 1.2%; Arsenic (As): Not more than 11 ppm; Cuprum (Cu): Not more than 320 ppm; Lead (Pb): Not more than 135 ppm; Total aerobic microbial count: Not more than 100 CFU/g; Moulds & Yeasts: Not more than 10 CFU/g; Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa: Negative/g; Salmonella: Negative/10g; Bacterial endotoxins: Less than 0.1 EU/mg Iron; Assay for Iron: 24.0% 32.0% (on the anhydrous basis); Assay for dextrin (as glucose): 25.0% 50.0% (on the anhydrous basis)

Betamethasone Dipropionate

Appearance: White or almost white crystalline powder; Identification[A: IR (2.2.24)]: Meets the requirements; Specific Optical Rotation (2.2.7): +84 +88; Particle Size: 98% pass through 30¼m sieve; Impurity C: Not more than 0.5%; Impurity B: Not more than 0.3%; Impurity H: Not more than 0.3%; Impurity D: Not more than 0.2%; Impurity E: Not more than 0.2%; Impurity G: Not more than 0.2%; Impurity I: Not more than 0.15%; Unspecified impurities: Not more than 0.1%; Total impurities: Not more than 1.0%; Loss on Drying (2.2.32): Not more than 1.0%; Assay (2.2.25): 97.0% 102.0% (on the anhydrous basis); N-Heptane: Not more than 5000 ppm; Acetone: Not more than 5000 ppm

Vildagliptin 274901-16-5

Character: White to yellowish white or grayish white powder; Identification: It exhibits most strongest absorption at the wave numbers of about 3293cm-1, 2915cm-1, 2238cm-1, 1659cm-1, 1407cm-1, 1355cm-1 and 1151cm-1; Heavy Metals: Not more than 10 ppm; L-Prolinamide: Not more than 0.10%; AHA: Not more than 0.10%; RRt about 0.6 impurity: Not more than 0.10%; Maximum impurity: Not more than 0.10%; Total impurities: Not more than 0.50%; RRt about 0.78 impurity: Not more than 0.10%; Water: Not more than 0.5%; Residue on Ignition: Not more than 0.1%; Assay: 98.5% 101.0%; Fatal foreign matter: 0; Critical foreign matter: Not more than 2; Minor foreign matter: Not more than 5; 2-Butanone: Not more than 5000 ppm; 2-Propanol: Not more than 5000 ppm; Dichloromethane: Not more than 600 ppm; Triethylamine: Not more than 5000 ppm

(3S)-3-(aminomethyl)-5-methyl-hexanoic acid Pregabalin

Appearance: White or almost white powder; Solubility: Sparingly soluble in water, very slightly soluble in methanol, practically insoluble in heptane; Identification(IR): IR spectrum is accordant with that of reference standard; Identification(HPLC): The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution in the Enantiomeric purity; Water: Not more than 0.5%; Sulfated Ash: Not more than 0.1%; Impurity A: Not more than 0.15%; Impurity C: Not more than 0.10%; Impurity D: Not more than 0.10%; Unspecified impurity: Not more than 0.10%; Total impurities: Not more than 0.50%; Enantiomeric purity (Impurity B): Not more than 0.15%; Ethanol: Not more than 5000 ppm; 2-Propanol: Not more than 5000 ppm; Tert-Butylmethyl ether: Not more than 5000 ppm; Tetrahydrofuran: Not more than 720 ppm; Assay (Calculated on the anhydrous basis): 98.0% 102.0%

Terbinafine Hydrochloride

Appearance: White or almost white powder; Solubility: Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methanol, slightly soluble in acetone; Identification A: Infrared absorption spectrophotometry. Comparison: terbinafine hydrochloride CRS; Identification B: It gives reaction (a) of chlorides using anhydrous ethanol R as solvent; Related Substances(Impurity B): Not more than 0.15%; Related Substances(Impurity E): Not more than 0.05%; Unspecified Impurities: Related Substances(Unspecified Impurities): each impurity not more than 0.1%; Related Substances(Sum of impurities): Not more than 0.3%; Loss on Drying: Not more than 0.5%; Sulphated Ash: Not more than 0.1%; Ethyl Acetate: Not more than 0.5%; Dichloromethane: Not more than 0.06%; Isopropanol: Not more than 0.5%; Particle Size: Meets the requirements; Assay: 99.0% 101.0%

Medetomidine C13H16N2

Appearance: Off-white to white powder; Residue on Ignition: Not more than 0.2%; Relative Substances(Individual impurity): Not more than 0.2%; Relative Substances(Total impurities): Not more than 1.0%; Heavy Metals: Not more than 20 ppm; Loss on Drying: Not more than 1.0%; Assay (on the anhydrous basis): 98.0% 102.0%

Levamisole Hydrochloride

Appearance: White or almost white crystalline powder; Solubility: Freely soluble in water, soluble in ethanol (96 percent), slightly soluble in methylene chloride; Identification(IR): Complies with reference spectrum of levamisole hydrochloride CRS; Chemical identification(Chloride): Positive; Impurity A: Not more than 0.2%; Impurity B: Not more than 0.2%; Impurity C: Not more than 0.2%; Impurity D: Not more than 0.2%; Impurity E: Not more than 0.2%; Individual unspecified impurities: Not more than 0.10%; Total impurities: Not more than 0.3%; Appearance of Solution: Clear, not more intensely colored than reference solution Y7; Loss on Drying: Not more than 0.5%; Sulphated Ash: Not more than 0.1%; Specific Optical Rotation (on the anhydrous basis): -121.0 -128.0; pH Value: 3.0 4.5; Assay (on the anhydrous basis): 98.5% 101.0%

Dexamethasone CAS No.: 50-02-2

Appearance: White or almost white crystalline powder; Identification A: Meets the requirements; Identification B: Meets the requirements; Impurity G: Not more than 0.3%; Impurity B: Not more than 0.15%; Impurity F: Not more than 0.15%; Impurity J: Not more than 0.15%; Impurity K: Not more than 0.15%; Unspecified impurity: Not more than 0.10%; Total impurities: Not more than 0.5%; Loss on Drying: Not more than 0.5%; Assay: 97.0% - 103.0% (on the anhydrous basis)

Ivermectin CAS No.: 70288-86-7

Appearance: White or yellowish-crystalline powder; Identification(IR): Corresponds with that of CRS Standard; Identification(HPLC): Corresponds with that of CRS Standard; Water: Not more than 1.0%; Appearance of Solution: Clear and not more intensely colored than BY7; Assay (on the anhydrous basis): 95.0% 102.0%; H2B1a/(H2B1a¼‹H2B1b): Not less than 90.0%; Individual impurities(RRT1.3-1.5): Not more than 2.5%; Any other individual impurities: Not more than 1.0%; Total impurities: Not more than 5.0%; Disregard limit: Not more than 0.05%; Ethanol: Not more than 5.0%; Formamide: Not more than 3.0%; Heavy Metals: Not more than 0.002%; Sulphated ash: Not more than 0.1%; Specific optical rotation (on the anhydrous and solvent-free basis): -17 -20

Dehydroepiandrosterone DHEA

Appearance: White-like crystalline powder; Melting Range: 148„ 151„; Loss on Drying: Not more than 0.5%; Assay: Not less than 99.0%

Semaglutide C187H291N45O59

Appearance: White or almost white loose powder; Solubility: Freely soluble in water Firstly , to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in 1ml. Then , to adjust the pH of the solution to 5.5 with 0.05M hydrochloric acid and keep for 30 seconds. Finally , to adjust the pH of the solution to 3.0 and keep 30 seconds. The solution should be turbid in the range of pH 3.0 to 5.5; Identification(By HPLC): The retention time of the principal peak of the test solution corresponds to that of the reference solution , as obtained in the Assay; Molecular Ion Mass: 4113.58ï1.0; Asp: 0.9 1.1; Ser: 2.7 3.3; Glu: 4.5 5.5; Gly: 3.6 4.4; His: 0.9 1.1; Arg: 1.8 2.2; Thr: 1.8 2.2; Ala: 2.7 3.3; Aib: 0.9 1.1; Tyr: 0.9 1.1; Val: 1.8 2.2; Lys: 0.9 1.1; Ile: 0.9 1.1; Leu: 1.8 2.2; Phe: 1.8 2.2; AEEA: Should be detected; pH Value: 7.0 9.0; Water Content(K. F): Not more than 10.0%; The clarity and color of the solution: Clear and colorless; Impurity A: Not more than 0.3%; Impurity B: Not more than 0.1%; Impurity C: Not more than 0.1%; Impurity D: Not more than 0.3%; Impurity E: Not more than 0.1%; Any individual impurity: Not more than 0.1%; Total impurities: Not more than 1.5%; Sodium Ion: 1.5% 4.0%; High molecular protein: Not more than 0.5%; Methylene Chloride: Not more than 600ppm; Acetonitrile: Not more than 410ppm; Methanol: Not more than 3000ppm; DMF: Not more than 880ppm; Isopropyl ether: Not more than 5000ppm; Isopropanol: Not more than 5000ppm; Bacterial Endotoxins: Not more than 10EU/mg; TAMC: Not more than 200CFU/g; TYMC: Not more than 100CFU/g; Trifluoroacetate ion: Not more than 0.1%; Phosphate ion: Not more than 0.1%; Chloride ion: Not more than 0.1%; Acetate ion: Not more than 0.1%; Assay(C187H291N45O59): 95.0% 105.0% (Calculated with reference to the anhydrous and sodium ion-free substance.)

Semaglutide delivery excipient Salcaprozate Sodium

Appearance: White to yellowish or pinkish crystalline powder; HPLC: The retention time of the main peak of the Sample solution corresponds to that of the Standard solution; UV: The maximum absorption should be at the wavelength of 301nm and 238nm , and the minimum absorption should be at the wavelength of 228nm; IR: Corresponding to Cholesterol CRS; Impurity A: Not more than 0.15%; Impurity E: Not more than 0.15%; Impurity G: Not more than 0.5%; The maximum unknown single impurity: Not more than 0.1%; Total impurities: Not more than 1.0%; Water: Not more than 2.0%; Heavy Metals: Not more than 0.002%; Arsenate: Not more than 0.0002%; Methyl Alcohol: Not more than 0.5%; Isopropanol: Not more than 0.5%; DMF: Not more than 0.088%; Ethyl Alcohol: Not more than 0.5%; Benzene: Not more than 0.0002%; Total Aerobic Microbial Count: Not more than 1000CFU/g; Total combined Yeasts & Moulds Count: Not more than 100CFU/g; Escherichia coli: Not detected; Residue on Ignition: Not more than 0.1%w/w; Sodium: 7.1% 8.1%(On the Anhydrous Basis); Salcaprozate Sodium: 98.0% 102.0%(On the Anhydrous Basis)

6- Methyluracil

Characteristics: White crystalline powder , odourless , bitter taste; Loss on Drying: Not more than 0.5%; Sulphated Ash: Not more than 0.1%; Heavy Metals: Not more than 0.001%; Assay: Not less than 99.0%; Chlorides: Not more than 0.015%

Methylliberine C9H12N4O3

Appearance: White or off-white crystalline powder; Identification: H-NMR conforms to the Standard; LC: Conforms to the Standard; Methylliberine Assay (HPLC): Not less than 98.0%; Liberine (HPLC): Not more than 1.0%; Other impurities (HPLC): Not more than 1.0%; Residue on Ignition: Not more than 0.5%; Loss on Drying: Not more than 1.0%; Particle Size: 95% pass through 80 mesh; Bulk Density: Not less than 0.20 g/mL; Tapped Density: Not less than 0.40 g/mL; Heavy Metals: Not more than 10 ppm; Lead (Pb): Not more than 0.5 ppm; Cadmium (Cd): Not more than 0.5 ppm; Mercury (Hg): Not more than 0.1 ppm; Arsenic (As): Not more than 0.5 ppm; Total Plate Count: Not more than 1000 CFU/g; Escherichia coli: Negative/10g; Coliforms: Not more than 10 CFU/g; Staphylococcus aureus: Negative/25g; Yeasts & Moulds: Not more than 100 CFU/g; Salmonella: Negative/375g

Sodium 8-(2-hydroxybenzamido)octanoate

Appearance: White/off-white solid; Identity: Meets the requirements; Purity: Not less than 90.0%; Impurity A: Not more than 0.15%; Impurity E: Not more than 0.15%; Impurity G: Not more than 0.5%; The maximum unknown single impurity: Not more than 1.0%; Total impurities: Not more than 10.0%; Isopropyl alcohol: Not more than 5000ppm; Methyl alcohol: Not more than 5000ppm; Ethanol: Not more than 5000ppm; DMF: Not more than 880ppm; Benzene: Not more than 2ppm

Semaglutide side chain HO-Ste-Glu(AEEA-AEEA-OSu)-OH

Appearance: White or off-white solid; Identity: Meets the requirements; Purity: Not less than 90.0%

Lamivudine C8H11N3O3S

Appearance: White or off-white crystalline powder; Solubility: Soluble in water, sparingly soluble in methanol; Identification(IR): The infrared absorption spectrum of the sample should be concordant with the standard spectrum; Identification(HPLC): The retention time of the major peak in the chromatogram of the Test solution should correspond to that in the chromatogram of the System suitability solution as obtained in the test for Limit of Lamivudine Enantiomer; Water by KF: Not more than 0.2%; Melting Range: 174ï 179ï; Specific Optical Rotation: -97 -99; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 20 ppm; Colour of the solution: The absorbance should not exceed 0.3; Related Substances(Impurity ï): Not more than 0.3%; Related Substances(Impurity ï): Not more than 0.2%; Related Substances(Impurity ï): Not more than 0.1%; Related Substances(Salicylic Acid): Not more than 0.1%; Related Substances(Any other individual impurity): Not more than 0.1%; Related Substances(Total impurities): Not more than 0.6%; Enantiomer: Not more than 0.3%; Assay: Between 98.0% and 102.0% on the anhydrous and solvent-free basis

Tranexamic Acid

Appearance: White crystalline powder; Identification: The infrared absorption spectrum is consistent with the reference spectrum of tranexamic acid; Solubility: Easily soluble in water and glacial acetic acid, insoluble in acetone and alcohol; pH Value: 7.0 8.0; Chloride: Not more than 140 ppm; Sulphated Ash: Not more than 0.1%; Heavy Metals: Not more than 10 ppm; Loss on Drying: Not more than 0.5%; Related Substances(Impurity A): Not more than 0.1%; Related Substances(Impurity B): Not more than 0.2%; Related Substances(Other impurities): Not more than 0.1%; Related Substances(Total impurities other than A and B): Not more than 0.2%; Content: 99.0% 101.0%

Semaglutide side chain TBuO-Ste-Glu(AEEA-AEEA-OH)-OtBu

Appearance: Off-white or yellowish paste solid; Identification: Meets the requirements; Purity: Not less than 95.0%; e.e. %: Not less than 98.0%; tBuO-Iso-Glu(AEEA-AEEA-OH)-OtBu (ZZ-28): Not more than 0.50%; tBuO-Pal-Glu(AEEA-AEEA-OH)-OtBu (ZZ-23): Not more than 0.50%; tBuO-Mar-Glu(AEEA-AEEA-OH)-OtBu (ZZ-18): Not more than 0.50%; tBuO-Non-Glu(AEEA-AEEA-OH)-OtBu (ZZ-13): Not more than 0.50%; tBuO-Ara-Glu(AEEA-AEEA-OH)-OtBu (ZZ-46): Not more than 0.50%; tBuO-Ste-Glu(OSu)-OtBu (ZZ-6): Not more than 0.50%; tBuO-Ste-Glu(AEEA-OH)-OtBu (ZZ-42): Not more than 0.50%; tBuO-Ste-Glu(AEEA-AEEA-OMe)-OtBu (ZZ-61): Not more than 1.00%; Sum: Not more than 5.0%; Moisture: Not more than 1.00%; Dichloromethane: Not more than 10000 ppm; Methyl alcohol: Not more than 5000 ppm; N-heptane: Not more than 5000 ppm; Isopropyl alcohol: Not more than 5000 ppm; n-Hexane: Not more than 290 ppm; Endotoxins: Not more than 2.0 EU/mg

Resmetirom intermediate 3,5-Dichloro-4-((6-Chloro-5-Isopropylpyridazin-3-Yl)Oxy)Aniline

Appearance: Off-white to yellow or brown or grey solid; Identification by HPLC: Conforms to retention time of the standard; Related Substances(L969-1): Not more than 0.50%; Related Substances(L969-3-Z7): Not more than 0.50%; Related Substances(L969-3-Z9): Not more than 0.30%; Related Substances(L969-3-Z10): Not more than 1.0%; Related Substances(Individual unspecified impurity): Not more than 0.30%; Related Substances(Total impurities): Not more than 2.0%; Assay by HPLC (w/w%)(On anhydrous and solvent free basis): 97.0% 102.0%; Water Content by KF (w/w%): Not more than 2.0%; Residual Solvents(Methanol): Not more than 3000 ppm; Residual Solvents(Dimethyl Sulfoxide): Not more than 5000 ppm; Residual Solvents(Dimethylformamide ): Not more than 880 ppm; Residual of Cu by ICP-MS: Not more than 300 ppm

Sermaglutide CAS No.: 910463-68-2

Appearance: White or off-white powder; Solubility: Freely soluble in water; Firstly, to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in 1ml. Then, to adjust the pH of the solution to 5.5 with 0.05M hydrochloric acid and keep for 30 seconds. Finally, to adjust the pH of the solution to 3.0 and keep 30 seconds. The solution should be turbid in the range of pH 3.0 to 5.5; Identification (HPLC): As obtained in the Assay, the difference between the retention time of the major peak of the sample solution and the reference solution should be less than 1 minute; Identification (Peptide Mapping): Peptide mapping of sample solution is similar to that of reference solution; Identification (N-terminal amino acid sequence): His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu; pH Value: 7.0 8.0; Water Content (K. F): Not more than 8.0%; Related Substances (Hydrophilic Impurities):Not more than 1.5%; Related Substances (Hydrophobic Impurities 1): Not more than 1.0%; Related Substances (Hydrophobic Impurities 2): Not more than 0.2%; Related Substances (Total Impurities): Not more than 2.0%; High Molecular Weight Proteins: Not more than 0.2%; Residual Solvents (Ethanol ): Not more than 0.5%; Residual Solvents (Acetonitrile): Not more than 0.041%; Residual Solvents (Dichloromethane): Not more than 0.06%; Biological Activity: Should be 0.7U 1.3U per 1mg; Residual Host Cell Protein: Not more than 100ng/mg; Residual Host Cell DNA: Not more than 10ng/mg; Bacterial Endotoxins: Not more than 10EU/mg; Microbial Limits (Total Aerobic Microbial Count): Not more than 100CFU/g; Microbial Limits (Total Yeasts and Moulds Count): Not more than 100CFU/g; Assay(C187H291N45O59): Containing Semaglutide 0.76mg 1.00mg per 1mg

Calcium Pyruvate 70%

Description: Slightly yellow or off-white crystalline powder; Loss on Drying: Not more than 10.0%; Heavy Metals: Not more than 10ppm; Arsenic(As): Not more than 1ppm; Chlorides: Not more than 200ppm; Sulfates: Not more than 400ppm; Calcium: Not less than 16.5%; Pyruvic Ion: Not less than 70.0%

Methyl Salicylate

Betadex Sulfobutyl Ether Sodium

Polyvinyl Pyrrolidone

Pharmaceutical peptide Retatrutide

Appearance: White or off-white powder; Molecular Ion Mass: 4731.42; Purity(HPLC): Not less than 98.0%; Sodium Ion(IC): Reported value; Water Content(K. F): Reported value; Peptide Content: Reported value

Dimethyl Sulfoxide

Assay: Not less than 99.90%; Water content: Not more than 0.10%; Acid Value: Not more than 0.03mgKOH/g; Crystallization Point: Not less than 18.10„; Refractive Index(nD20„): 1.4775 1.4790; Transmittance(400nm): Not less than 96.00%

Fursultiamine Fursutiamine

Appearance: White or slight yellow crystalline powder , garlic likeness odour; Solubility: Freely soluble in methanol , ethanol or chloroform , slightly soluble in water or acetone , practically insoluble in ether or benzene; Melting Point: 130„ 136„ , with decomposition; Specific Absorbance: 280 300; Identification: Should be positive; Clarity: Solution should be clear; Chlorides: Not more than 0.014%; Thiamine: Meets the requirements; Loss on Drying: Not more than 0.5%; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 20ppm; Assay(Titration): Not less than 99.0%(on the anhydrous basis); Total Plate Count: Not more than 1000CFU/g; Yeasts & Moulds: Not more than 100CFU/g; Escherichia coli: Negative

Pharmaceutical Peptide Semaglutide

Appearance: White or off-white powder; Solubility: Freely soluble in water Firstly , to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in 1ml. Then , to adjust the pH of the solution to 5.5 with 0.05M hydrochloric acid and keep for 30 seconds. Finally , to adjust the pH of the solution to 3.0 and keep 30 seconds. The solution should be turbid in the range of pH 3.0 to 5.5; Identification(HPLC): As obtained in the Assay , the difference between the retention time of the main peak of the sample solution and the reference solution should be less than 1 minute; Identification(Peptide Mapping): Peptide mapping of sample solution is similar to that of reference solution; pH Value: 7.0 8.0; Water Content(K. F): Not more than 8.0%; Hydrophilic Impurities: Not more than 2.4%; Hydrophobic Impurities 1: Not more than 2.1%; Hydrophobic Impurities 2: Not more than 0.3%; Total Impurities: Not more than 4.5%; High Molecular Weight Proteins: Not more than 0.2%; Ethanol: Not more than 0.5%; Acetonitrile: Not more than 0.041%; Dichloromethane: Not more than 0.06%; Biological Activity: Should be 80.0% 120.0% of the reference; Residual Host Cell Protein: Not more than 100ng/mg; Residual Host DNA: Not more than 10ng/mg; Bacterial Endotoxins: Not more than 10EU/mg; Total Aerobic Microbial Count: Not more than 100CFU/g; Total Yeasts and Moulds Count: Not more than 100CFU/g; Assay(C187H291N45O59): Containing Semaglutide 0.76mg 1.00mg per 1mg

Finerenone BAY 94-8862