Pharmaceutical Excipients

POLY(D L-LACTIDE-CO-GLYCOLIDE)

Appearance: White or yellow particles; Intrinsic viscosity: 0.2 dL/g 2.5 dL/g; Viscosity-average Molecular Weight: 1 400000; Number-average molecular weight: 1 400000; Glass transition temperature: 40ï 60ï; Residual monomer: Less than 1%; Residual solvents: Less than 0.05%; Heavy metals: Less than 10 ppm; Density: 1.20g/cm3 1.30g/cm3; Sulphated ash: Less than 0.05%

Injection Grade Soya Lecithin

Characters: Yellow to brown semisolid or lumps; Acid Value: Not more than 12 mgKOH/g; Iodine Value: 90 gI/100g 110 gI/100g; POV: Not more than 3.0; 350nm Luster: Not more than 0.5; Moisture: Not more than 1.5%; Protein Content: Consistent with standard requirements; Heavy Metals: Not more than 0.0005%; Arsenic salts: Not more than 0.0002%; Lead(Pb): Not more than 0.0002%; Residual ethanol: Not more than 0.2%; Residual acetone: Not more than 0.2%; Residual diethyl ether: Not more than 0.2%; Residual petroleum ether: Not more than 0.05%; Residual n-hexane: Not more than 0.02%; Residual solvent: Not more than 0.5%; LPE: Not more than 0.5%; LPC: Not more than 3.5%; LPC+LPE: Not more than 4.0%; PI: Not more than 5.0%; Total related substance: Not more than 8.0%; Total number of aerobe, moulds and yeasts: Not more than 100 CFU/g; Escherichia coli: Negative/g; Salmonella: Negative/10g; Bacterial endotoxins: Less than 2.0 EU/g; P: Not less than 3.3%; N: 1.5% 2.0%; PC: Not less than 88.0%; PE: Not more than 20.0%; PC+PE: Not less than 88.0%

Benzoic Acid

Appearance: White or almost white, crystalline powder or colourless crystals; Identification: Passes the test; Appearance of solution: Clear and Colourless; Content (On the anhydrous basis): 99.0% 100.5%; Oxidizable substances: Passes the test; Carbonizable substances: Lighter than Y5; Halogenated compounds and halides: Not more than 300 ppm; Sulfated ash: Not more than 0.1%

Vitamin E Polyethylene Glycol Succinate

Description: White to yellowish waxy solid; Identification: Meets the requirements; Assay(D-±-tocopherol): Not less than 26.0%; mono-TPGS: Not less than 80.0%; bis-TPGS: Not more than 10.0%; Vitamin E: Not more than 1.5%; Vitamin E Succinate: Not more than 0.2%; Solubility in water: 20% Min(Clear solution within 3h); Acidity: Not more than 1.5; Specific Rotation: Not less than +24.0; Heavy Metals: Not more than 10ppm; Ethyl Acetate: Not more than 50ppm; Ethanol: Not more than 200ppm; Total Plate Count: Not more than 1000CFU/g; Yeasts & Moulds: Not more than 100CFU/g; Salmonella: Negative; Escherichia coli: Negative

Polyvinyl Pyrrolidone (PVP) K90

Identification(A , B , C): Meet the requirements; pH Value(5% Aqueous Solution): 3.0 7.0; Water(Karl Fischer): Not more than 5.0%; Residue on Ignition: Not more than 0.1%; Lead(Pb): Not more than 10 ppm; Aldehyde: Not more than 0.05%; Residual Monomer: Not more than 0.2%; K Value: 81.0 97.2; Nitrogen Content: 11.5% 12.8%; Microbial Content: Conforms to USP26 Standard

Betadex Sulfobutyl Ether Sodium

Appearance: White to off-white , amorphous powder; Identification(IR): Same absorption bands as USP betadex sulfobutyl ether sodium RS; Identification(HPLC): The retention time of the major peak of sample solution corresponds to the standard solution; Identification(Average degree of substitution): Conforms; Identification(Sodium): Identify test are positive for Sodium; Assay(on the anhydrous basis): 95.0% 105.0%; Betadex: Not more than 0.1%; 1 , 4-butane sultone: Not more than 0.5 ppm; Sodium chloride: Not more than 0.2%; 4-hydroxybutane-1-sulfonic acid: Not more than 0.09%; Bis(4-sulfobutyl) ether disodium: Not more than 0.05%; The total aerobic microbial count: Not more than 100 CFU/g; The total combined moulds & yeasts count: Not more than 50 CFU/g; Escherichia coli: Negative; Clarity of solution: 30%(w/v) solution is clear and essentially free from particles of foreign matter; Average degree of substitution: 6.2 6.9; pH Value: 4.06.8; Water determination: Not more than 10.0%

L-A-Lecithin Distearoyl

Appearance: White powder; Identification: Meets the requirements; Purity: Not less than 95.0%; Moisture: Not more than 1.0%

Sodium 8-(2-hydroxybenzamido) Octanoate SNAC

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

Pharmaceutical Grade Sodium Stearate

Appearance: Fine white light powder; Identification A: Meets the requirements; Identification B: Meets the requirements; Acid value of fatty acids: 196 211; Iodine value of fatty acids: Not more than 4.0; Acidity: 0.28% 1.20%; Loss on Drying: Not more than 5.0%; Alcohol-insoluble substances: Meets the requirements; Stearic acid: Not less than 40.0%; Stearic acid & palmitic acid: Not less than 90.0%

Pharmaceutical Grade Fructose

Appearance: White crystalline powder; Solubility: Very soluble in water , soluble in ethanol; Identification(Infrared absorption): Meets the requirements; Colour of Solution: Meets the requirements; Acidity: Not more than 0.20 ml; Loss on Drying: Not more than 0.5%; Residue on Ignition: Not more than 0.1%; Assay: 98.0% 102.0%; Chloride: Not more than 0.01%; Sulfate: Not more than 0.01%; Arsenic(As): Not more than 1 ppm; Calcium and Magnesium: Not more than 0.005%; Limit of hydroxymethylfurfural: Meets the requirements; Total plate count: Not more than 1000 CFU/g; Moulds & yeasts: Not more than 100 CFU/g; Escherichia coli: Negative/g; Salmonella: Negative/10g

Pharmaceutical Grade Magnesium Stearate

Appearance: A white , very fine , light , powder , greasy to touch; Identification A: The tests for Magnesium; Identification B: Conforms; Acidity or alkalinity: Conforms; Loss on Drying: Not more than 6.0%; Chloride: Not more than 0.1%; Sulphates: Not more than 1.0%; Lead(Pb): Not more than 10ppm; Cadmium(Cd): Not more than 1ppm; Nickel(Ni): Not more than 5ppm; Stearic Acid: Not less than 40.0%; Stearic Acid & Palmitic Acid: Not less than 90.0%; Assay(Mg): 4.0% 5.0%; TAMC: Not more than 1000CFU/g; TYMC: Not more than 500CFU/g; Escherichia coli: Negative; Salmonella species: Negative; Specific surface area: /

Salcaprozate Sodium (SNAC)

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: ï0.15%; Impurity E: ï0.15%; Impurity G: ï0.5%; The maximum unknown single impurity: ï0.1%; Total impurities: ï1.0%; Water: ï2.0%; Heavy Metals: ï20ppm; Arsenate: ï0.0002%; Methyl Alcohol: ï0.5%; Isopropanol: ï0.5%; DMF: ï0.088%; Ethyl Alcohol: ï0.5%; Benzene: ï0.0002%; TAMC: ï1000CFU/g; TYMC: ï100CFU/g; E. coli should not be detected per 1g; Residue on Ignition: ï0.1%w/w; Sodium: 7.1% 8.1%(On Dried Basis); Salcaprozate Sodium: 98.0% 102.0%(On Dried Basis)

Microcrystalline Cellulose 101

Identification: Positive; pH Value: 5.0 7.5; Ether-soluble Matter: Not more than 0.05%; Water-soluble Matter: Not more than 0.25%; Conductivity: Not more than 75 S/cm; Heavy Metals: Not more than 10 ppm; Residue on Ignition: Not more than 0.1%; Loss on Drying: Not more than 7.0%; Bulk Density: 0.32 g/mL 0.42 g/mL; Particle Size: 1) Not less than 99% pass through 60 mesh sieve 2) Not less than 70% pass through 200 mesh sieve; Total Plate Count: Not more than 1000 CFU/g; Total Yeasts & Moulds: Not more than 100 CFU/g; Escherichia coli: Negative; Salmonella: Negative; Staphylococcus aureus: Negative; Pseudomonas aeruginosa: Negative

Pharmaceutical Grade Chitosan

Appearance: Off-white powder; Viscosity: Meets the requirements; Moisture: Not more than 10.0%; Ash: Not more than 1.0%; pH Value: 5.0 8.0; Insoluble Substance: Not more than 0.5%; Heavy Metals: Not more than 10 ppm; Protein: Not more than 0.2%; DAC degree: Not less than 90%; Endotoxin: Not more than 0.5 EU/mg

Pharmaceutical Grade Chitosan Hydrochloride

Appearance: Off-white powder or light yellow powder; DAC degree: Not less than 90.0%; Viscosity: Meets the requirement; Moisture: Not more than 10.0%; Ash content: Not more than 0.5%; Chloride: 10.0% 20.0%; pH Value: 4.0 6.0; Protein: Not more than 0.2%; Endotoxin: Not more than 0.5EU/mg; Particle Size: Meets the requirement; Heavy Metals: Not more than 10 ppm; Total Plate Count: Not more than 1000 CFU/g; Yeasts & Moulds: Not more than 100 CFU/g; Escherichia coli: Negative; Salmonella: Negative

Lactose Anhydrous

Appearance: White or almost white crystalline powder; Solubility: Freely but lowly soluble in water , practically insoluble in ethanol(96%); Identification A: The infrared absorption spectrum of the sample is concordant with that of the standard; Identification B: The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots , disregarding any spots at the origin; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 5 g per g; Clarity and Colour of Solution: 1) The solution(1g in 10 ml of boiling water) is clear and nearly colourless. 2) Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length , in cm , which is not more than 0.04; Optical Rotation: 54.4 +55.9 , calculated on the anhydrous basis , determined at 20ï; Acidity or alkalinity: Adding 0.3 ml of phenolphthalein TS: the solution is colourless , and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red colour; Loss on Drying: Not more than 0.5% after drying a sample at 80ï for 2 hours; Water: Less than 1.0%; Protein and light-absorbing impurities(210 nm 220 nm): Not more than 0.25; Protein and light-absorbing impurities(270 nm 300 nm): Not more than 0.07; Total Plate Count: Less than 100 CFU/g; Yeasts & Moulds: Less than 50 CFU/g; Escherichia coli: Negative/10g; Assay The chemical name of this product is O--D-galactopyranosyl-(1ï4))--D-glucopyranos anhydrate. The content of C12H22O11 should be between 98.0% and 102.0%; Acidity: Taking 1.0 g of this product , and the pH value should be between 4.0 and 7.0.

Pharmaceutical Grade Carboxymethyl Chitosan

Appearance: Off-white or light yellow flakes or powder; Degree of Carboxylation: Not less than 80%; Viscosity: Not more than 100mpaïs; pH Value: 6.0 10.0; Assay: Not less than 85.0%; Loss on Drying: Not more than 15.0%; Residue on Ignition: Meets the requirements; Insoluble Matter: Not more than 0.5%; Residual Protein: Not more than 0.2%; Residual Ethanol: Not more than 0.5%; Residual Diglycolic Acid: Not more than 0.1%; Endotoxin: Less than 0.5EU/mg , Less than 0.05EU/mg or customized standard; Heavy Metals: Not more than 10mg/kg; Total Arsenic(As): Not more than 4.0mg/kg; Mercury(Hg): Not more than 4.0mg/kg; Iron(Fe): Not more than 50mg/kg; Total Plate Count: Not more than 100CFU/g; Moulds & Yeasts: Not more than 10CFU/g; Escherichia coli: Negative

Methoxypoly (Ethylene Glycol) Dimyristoyl Glycerol-2000

Appearance: White powder-like solid; Identity(IR): Complies with the reference substance structure; Identity(H-NMR): Complies with the reference substance structure; Identity(Average molecular weight): 2500ï200 Da; Assay: 90.0% 110.0%; Purity: Not less than 95.0%; Polydispersity(Mw/Mn): Not more than 1.05; Myr-OH: Not more than 1.00%; mPEG-LMG-2K(-28): Not more than 1.00%; mPEG-TMG-2K(-14): Not more than 1.00%; mPEG-IMG-2K(+14): Not more than 1.00%; mPEG-PMG-2K(+28): Not more than 1.00%; mPEG-MA-2K: Not more than 1.00%; mPEG-MG-2K(): Not more than 1.00%; mPEG-MG-2K(): Not more than 1.00%; Myr-EDU: Not more than 1.00%; mPEG-DOH-2K: Not more than 1.00%; TMG: Not more than 1.00%; EDU: Not more than 1000 ppm; DMAP: Not more than 1000 ppm; DMG-PEG-DMG-4K: Not more than 1.00%; Isopropanol: Not more than 5000 ppm; Dichloromethane: Not more than 600 ppm; n-Hexane: Not more than 290 ppm; Tetrahydrofuran: Not more than 720 ppm; Ethyl Acetate: Not more than 5000 ppm; Copper(Cu): Not more than 30 ppm; Arsenic(As): Not more than 1.5 ppm; Chromium(Cr): Not more than 0.2 ppm; Mercury(Hg): Not more than 0.3 ppm; Lead(Pb): Not more than 0.5 ppm; Cobalt(Co): Not more than 0.5 ppm; Vanadium(V): Not more than 1.0 ppm; Nickel(Ni): Not more than 2.0 ppm; Lithium(Li): Not more than 25 ppm; Antimony(Sb): Not more than 9 ppm; Moisture: Not more than 1.00%; TAMC/g: Not more than 100 CFU/g; TYMC/g: Not more than 10 CFU/g; Endotoxin: Not more than 0.015 EU/mg

LNP delivery system excipient mPEG-DSPE-2K

Appearance: White or off-white solid; Identity: Meets the requirements; Substitution: Not less than 95.0%; Average molecular weight(raw material): 2 , 000 ï 200 Da; Polydispersity(Mw/Mn)(raw material): Not more than 1.05

Sodium Lactate 60% Solution

Appearance: Clear, colourless or practically colourless, slightly viscous liquid, odourless or having a slight but not unpleasant odour; Solubility: Miscible with water; Identification(Sodium): It responds to the tests for Sodium; Identification(Lactate): It responds to the tests for Lactate; pH Value: 5.0 9.0; Chloride: Not more than 0.05%; Sulfate: No turbidity is produced; Sugar: No red precipitate is formed; Citrate, oxalate, phosphate, tartrate: The solution remains clear; Methanol and methylesters: The absorbance of the solution: ï0.025%; Assay: 60.0% 61.2%; Total number of aerobic bacteria: Not more than 1000 CFU/g; Total number of moulds and yeasts: Not more than 100 CFU/g; Escherichia coli: Negative/g; Bacterial endotoxins: Not more than 5 IU/mL

Lactose Monohydrate

Appearance: White free-flowing powder; Solubility: Freely but slowly soluble in water, practically insoluble in alcohol; Identification A: The retention of the main peak of the test solution in the chromatogram recorded under the content determination item should be consistent with the retention time of the main peak of the reference solution; Identification B: The infrared light absorption profile of the product should be consistent with that of the control; Optical Rotation: +54.4 +55.9; Acidity/Alkalinity: Take 6.0g of this product and check according to law, the solution is colourless, and not more than 0.4ml of 0.1 N sodium hydroxide is required to produce a pink to red colour; Clarity and Colour of Solution: Take 1.0g of this product, add 10ml boiling water to dissolve, check according to law, the solution should be clear and nearly colourless Take this product, determine according to law, measure absorbance at 400nm wavelength, not more than 0.04; Protein and impurity absorbance(210nm 220nm): Not more than 0.25; Protein and impurity absorbance(270nm 300nm): Not more than 0.07; Loss on Drying: Not more than 0.5%; Water: 4.5% 5.5%; Residue on Ignition: Not more than 0.1%; Heavy Metals: Not more than 5ppm; Arsenic Salt: Take the residue under the burning residue, check according to law, should comply with the regulations (0.0002%); Total Aerobic Microbial Count: Not more than 100CFU/g; Total Yeasts and Moulds Count: Not more than 50CFU/g; Escherichia coli: Negative/g; Content: The chemical name of this product is 4-O-beta-D-Galactopyranosyl-D-glucose. Containing C12H22O11 should be between 98.0% and 102.0%; Rotap Particle Size: Not less than 80% pass through 75¼m sieve Not less than 99% pass through 150¼m sieve

Microcrystalline Cellulose