Pepsin


CAS NO. : 9001-75-6

Pharmacopoeia standard :/ CP / EP / USP

HS CODE : 3507.9090.90

File service:Chinese GMP / DMF   / EU-DMF


Source:Porcine gastric mucosa.

Characters:White or slightly yellow, crystalline or amorphous powder.

ProcessPepsin is isolated from the pig's gastric mucosa using a unique extraction technique.



Product details



Test Items

Company Specification

CP

EP

USP

Characters

White to light yellow powder;

no mildew and deodorant; hygroscopic,

the aqueous solution shows acidic reaction

White or slightly yellow,

crystalline or amorphous powder

White or slightly yellow,

crystalline or amorphous powder

Identification

Conforms

Conforms

Conforms

Tests

Loss on drying

≤ 5.0% (Dry environment100℃, 4h)

≤ 5.0% (670Pa 60℃, 4h)

≤ 5.0% (Vacuum decompression 60℃, 4h)

Residual solvent

————

≤ 5.0%According to EP(5.4)

≤ 5.0%According to USP(467)

Assay

3800~12000U/g

0.5~4.5Ph.Eur.U./mg

3000~20000NF.U/mg

Microbial

Impurities

TAMC

≤5X103cfu/g

≤ 10000cfu/g

≤ 10000cfu/g

TYMC

≤ 100cfu/g

≤ 100cfu/g

≤ 100cfu/g

E.coli

Conforms

Conforms

Conforms

Salmonella

Conforms

Conforms

Conforms





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