Trypsin
Source: Bovine (Porcine) pancreas
General description
Trypsin is a kind of serine protein hydrolase, exclusive role in composed of alkaline amino acids arginine and leucine peptide bond, soluble in **, insoluble in chloroform, ethanol, ethyl ether, and glycerin, Ca2 + is protection for trypsin and activation function.
Manufacture
Trypsin production of Beijing Geyuantianrun Bio - tech Co., ltd. is by protein chromatography technology preparation, reach the standard pharmaceutical raw materials.
Application
Specification
|
Items |
Specification |
Standard |
|
Appearance |
White or almost white lyophilized powder |
USP35 |
|
Solubility |
500,000USP Trypsin Units is soluble in 10ml of ** and in 10ml of saline TS. |
USP35 |
|
Loss on drying |
No more than 5.0% |
USP35 |
|
Residue on Ignition |
No more than 2.5% |
USP35 |
|
Microbial limits： Pseudomonas aeruginosa Salmonella Staphylococcus aureus |
Absent |
USP35 |
|
Chymotrypsin |
No more than 50 USP units/mg powder |
USP35 |
|
Assay |
Trypsin ≥ 2500USP units/mg powder |
USP35 |
|
|
|
|
|
Items |
Specification |
Standard |
|
Description |
white crystalline powder |
EP6.0 |
|
Identification |
A) A purple color develops within 3 minutes B) No purple color develops with in 3 minutes |
EP6.0 |
|
Appearance of solution |
Solution S is not more opalescent than reference suspension Ⅲ |
EP6.0 |
|
Absorbance |
1) 280nm : 13.5 ~ 16.5 2) 250nm : not more than 7.0 |
EP6.0 |
|
PH |
3.0-6.0 |
EP6.0 |
|
Histamine |
Not more than 1µg/0.2µkatal |
EP6.0 |
|
Loss on drying |
Not more than 5% |
EP6.0 |
|
Limit of chymotrypsin |
Not more than 1% |
EP6.0 |
|
Microbial limits Total viable aerobic count Salmonella E.Coli |
≤10000cfu/g Absent Absent |
EP6.0 |
|
Assay |
Not less than 0.5µkatal /mg, calculated on the dried basis. |
EP6.0 |
來源：豬（牛）胰腺
概述
胰糜蛋白酶是糜蛋白酶和胰蛋白酶的混合晶體，具有兩種酶的性質。水解酪蛋白的活力與糜蛋白酶相當，水解苯甲酰酪氨酸乙酯的活力相當于糜蛋白酶的3倍，水解酯鍵的活力與胰蛋白酶相似。干燥情況下穩(wěn)定，液體狀態(tài)易失活，PH7—8時活性最強。
北京格源天潤生物技術有限公司生產的糜胰蛋白酶是通過多重結晶方式純化，并進一步采取超濾技術制備而得。
用途
質量規(guī)格 6：1
|
項目 |
規(guī)格 |
執(zhí)行標準 |
|
性狀 |
白色或類白色粉末 |
企業(yè)標準 |
|
灼燒殘渣 |
不得超過2.5% |
美國藥典37版 |
|
干燥失重 |
不得超過5.0% |
美國藥典37版 |
|
效價測定 |
胰蛋白酶 ≥ 2400單位/毫克 糜蛋白酶 ≥ 400單位/毫克 |
企業(yè)標準 |
