Certificate of Analysis and technical specification for Orotic Acid — CAS 65-86-1. Applies to all consignments of this product and grade.
| Product Name | Orotic Acid |
|---|---|
| C.A.S. Number | 65-86-1 |
| Product Category | Nutraceuticals & Herbal Extracts |
| Product Group | Vitamin B13 |
| Grade / Standard | ≥98% Technical |
| Physical Form | White crystalline powder |
| Country of Origin | India |
| Packing | Standard export packing — bags, drums, carboys, IBC or ISO tank as applicable |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
| 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 | Assay | Not less than 98.0 % w/w | 98.87 | Titrimetry / Instrumental |
| 5 | Loss on Drying | Not more than 5.0 % w/w | 3.37 | Gravimetry |
| 6 | Total Ash | Not more than 5.0 % w/w | 2.42 | Gravimetry |
| 7 | Bulk Density | As per specification | 0.51 g/mL | Tapped density |
| 8 | Particle Size — through 80 mesh | Not less than 95 % | 97.6 | Sieve analysis |
| 9 | Pesticide Residues | Complies with USP <561> | Complies | GC-MS / LC-MS |
| 10 | Aflatoxins (B1, B2, G1, G2) | Not more than 20 ppb | Less than 2 ppb | HPLC-FLD |
| 11 | Residual Solvents | Complies with ICH Q3C | Complies | Headspace GC |
| 12 | Lead (Pb) | Not more than 3.0 ppm | Less than 0.5 ppm | ICP-MS |
| 13 | Heavy Metals (as Pb) | Not more than 10 ppm | Less than 5 ppm | ICP-OES |
| 14 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 52 cfu/g | IP / USP <61> |
| 15 | Total Yeast & Mould Count | Not more than 100 cfu/g | 19 cfu/g | IP / USP <61> |
| 16 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 17 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
This document sets out the standard specification for Orotic Acid and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.
Send the specification you work to — we confirm the grade, packing, documentation set and CIF/FOB price within one business day.
