Category:
Other Excipients
CAS NO:
9004-07-3
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Basic Info
Grade
Pharmaceutical Grade
Product Keywords
Chymotrypsin
Is Manufacturer
YES
Product Description
A proteolytic enzyme secreted by the pancreas, CAS No.: 9004-07-3, which can rapidly decompose denatured proteins. Its function and applications are similar to those of trypsin, but it exhibits stronger decomposition capability, lower toxicity, and fewer adverse effects compared to trypsin.
| Items 检测项目 | Specification 标准规定 |
| 1. Characters 性状 | 1.1 Appearance: White or almost white, crystalline or amorphous powder, hygroscopic if amorphous. 外观：白色或类白色结晶性或无定形粉末，无定形粉末有引湿性。 1.2 Solubility: Sparingly soluble in water. 溶解性：略溶于水。 |
| 2. Identification 鉴别 | A. A purple colour develops. 应显紫色。 B. No colour develops within 3 min of mixing. 3分钟内不得显色。 |
| 3. Appearance of solution 溶液的澄清度 (10 mg/ml) | Not more opalescent than reference suspension Ⅱ. ≤Ⅱ号浊度标准液。 |
| 4. pH (10 mg/ml) | 3.0-5.0 |
| 5. Specific absorbance 吸收系数 | OD281nm: 18.5-22.5 OD250nm: ≤ 8.0 |
| 6. Trypsin 胰蛋白酶 | No colour appears in the test solution within 3-5 min after the addition of the substrate solution. A purple colour is produced in the control solution. 加入底物溶液后，供试品3～5分钟内不得显色；对照溶液显紫色。 |
| 7. Loss on drying 干燥失重 | ≤5.0 % |
| 8. Activity 效价 | ≥ 5.0 microkatals/mg |
| 9. MicrobiaI contamination 微生物污染 | |
| (1) TAMC 需氧菌总数 | ≤ 103CFU/g |
| (2) TYMC 霉菌和酵母菌总数 | ≤ 102 CFU/g |
| (3) Bile-tolerant gram- negative bacteria 耐胆盐革兰氏阴性菌 | ≤ 102 CFU/g |
| (4) Staphylococcus aureus 金黄色葡萄球菌 | Absence/g 不得检出/g |
| (5) Pseudomonas aeruginosa 铜绿假单胞菌 | Absence/g 不得检出/g |
| (6) Escherichia coli 大肠埃希菌 | Absence/g 不得检出/g |
| (7) Salmonella species 沙门菌 | Absence/10g 不得检出/10g |
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