Pepsin
【Approval No.】 GUOYAOZHUNZI H51021992
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.
Process：Pepsin is isolated from the pig's gastric mucosa using a unique extraction technique.
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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