Scapex Exports Pvt. Ltd.
830, 8th Floor, Sun Gravitas, Times of India Road,
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Certificate of AnalysisStandard product specification
N-Acetyl-L-Histidine Hydrate
CAS 2497-02-1 · C8H13N3O4 · Fine chemical grade — assay on specification
Structural formula1. Product identity
| Product name | N-Acetyl-L-Histidine Hydrate |
|---|---|
| C.A.S. number | 2497-02-1 |
| Molecular formula | C8H13N3O4 |
| Molecular weight | 215.21 g/mol |
| Grade / standard | Fine chemical grade — assay on specification |
| Description | White crystalline powder |
| Product group | Amino Acids |
| Category | Vitamins, Minerals & Amino Acids |
| Country of origin | India |
| Packing | Bags, drums, carboys, IBC or ISO tank as applicable — customer-specified packing available |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
2. Analytical specification
| S. No. | Test parameter | Specification | Typical result | Method |
|---|---|---|---|---|
| 1 | Description | White crystalline powder | Complies | Visual |
| 2 | Identification | Conforms to the structure of the substance | Complies | FTIR / Chemical test |
| 3 | Solubility | As per specification | Complies | Visual / Monograph |
| 4 | Specific Optical Rotation | As per monograph | Conforms | Polarimetry |
| 5 | Loss on Drying | Not more than 0.5 % w/w | 0.27 | Gravimetry |
| 6 | Residue on Ignition | Not more than 0.1 % w/w | 0.042 | Gravimetry |
| 7 | Chloride | Not more than 0.05 % | 0.0042 | Turbidimetry |
| 8 | Lead (Pb) | Not more than 3 ppm | Less than 0.5 ppm | ICP-MS |
| 9 | Heavy Metals (as Pb) | Not more than 10 ppm | Less than 5 ppm | ICP-OES |
| 10 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 82 cfu/g | IP / USP <61> |
| 11 | Total Yeast & Mould Count | Not more than 100 cfu/g | 7 cfu/g | IP / USP <61> |
| 12 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 13 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
3. Declaration
This document sets out the standard specification for N-Acetyl-L-Histidine Hydrate and applies to all consignments of this product and grade supplied by Scapex Exports Pvt. Ltd. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with, and travels with, each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we confirm compliance in writing before the order is accepted.
SCAPEXQUALITY ASSURED