APIs And Intermediates

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%

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

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%

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)

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%

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

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%

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

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%

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

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

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