L-Cysteine HCL Monohydrate
EP, USP + LEC + Microbiological requirements
CAS #:
7048-04-6
Molecular Formula:
C3H8ClNO2S . H2O
Synonym:
L-2-Amino-3-mercaptopropanoic Acid Hydrochloride
Molecular Weight:
175.64 g/mol
Overview
L-Cysteine Hydrochloride, Monohydrate, USP is a semi-essential amino acid and can be biosynthesized in humans. It is often used as a food additive. Its FCC grade meets the requirements of the Food Chemical Codex indicates and is suitable for all food, beverage and nutritional supplement applications.
| Characters | Unit | Specification |
|---|---|---|
| Identity A (EP) | Correlates to test | |
| Identity B (EP) | Correlates to test | |
| Identity E (EP) | Correlates to test | |
| Identity A (USP) | Correlates to test | |
| Appearance of solution (EP) | Correlates to test | |
| Impurity A at 570 nm (EP) | % | ≤ 0.5 |
| Any ninhydrin positive substance (EP) | % | ≤ 0.2 |
| Total Impurities (EP) | % | ≤ 1.0 |
| Individual Impurities (USP) | % | ≤ 0.5 |
| Total Impurities (USP) | % | ≤ 2.0 |
| Assay (EP) | % | 98.5 - 101.0 |
| Assay (USP) | % | 98.5 - 101.5 |
| Residue on lgnition | % | ≤ 0.4 |
| Sulphated Ash | % | ≤ 0.1 |
| Ammonium | mg/kg | ≤ 200 |
| Sulfate | mg/kg | ≤ 300 |
| Iron | mg/kg | ≤ 20 |
| Heavy Metals | mg/kg | ≤ 10 |
| Specific optical rotation (EP) | o | 5.5 - 7.0 |
| Specific optical rotation (USP) | o | 5.7 - 6.8 |
| Loss on drying (EP) | % | 8.0 - 12.0 |
| Loss on drying (USP) | % | 8.0 - 12.0 |
| Bacteria Endotoxins | IU/g | ≤ 5 |
| TAMC | CFU/g | ≤ 50 |
| TYMC | CFU/g | ≤ 10 |
| Escherichia coli | CFU/g | |
| Staphylococcus aureus | CFU/g | |
| Pseudomonas aeruginosa | CFU/g | |
| Salmonella | CFU/10g |
Shelf Life/Retest Date: L-Cysteine HCL Monohydrate raw material can be kept for at least 2 years if stored in a cool and dry place
Storage/Shipping Conditions:
- Keep containers tightly closed in a dry, cool and well-ventilated place.
- Protected from light.
- Storage temperature recommended: < 25°C
Pack Sizes: 100 gm
