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 |
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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 |
来源:猪(牛)胰腺
概述
胰糜蛋白酶是糜蛋白酶和胰蛋白酶的混合晶体,具有两种酶的性质。水解酪蛋白的活力与糜蛋白酶相当,水解苯甲酰酪氨酸乙酯的活力相当于糜蛋白酶的3倍,水解酯键的活力与胰蛋白酶相似。干燥情况下稳定,液体状态易失活,PH7—8时活性**强。
北京格源天润生物技术有限公司生产的糜胰蛋白酶是通过多重结晶方式纯化,并进一步采取超滤技术制备而得。
用途
质量规格 6:1
项目 |
规格 |
执行标准 |
性状 |
白色或类白色粉末 |
企业标准 |
灼烧残渣 |
不得超过2.5% |
美国药典37版 |
干燥失重 |
不得超过5.0% |
美国药典37版 |
效价测定 |
胰蛋白酶 ≥ 2400单位/毫克 糜蛋白酶 ≥ 400单位/毫克 |
企业标准 |