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
Tribulus Terrestris Extract 40% Saponins
Formulated product · 40% Saponins HPLC
1. Product identity
| Product name | Tribulus Terrestris Extract 40% Saponins |
|---|---|
| C.A.S. number | Applicable to blend — on request |
| Grade / standard | 40% Saponins HPLC |
| Description | Light tan fine powder |
| Product group | Vitality Extracts |
| Category | Nutraceuticals & Herbal Extracts |
| 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 | Light tan fine powder | Complies | Visual |
| 2 | Solubility | As per specification | Complies | Visual / Monograph |
| 3 | Assay | Not less than 40.0 % w/w | 41.26 | Titrimetry / Instrumental |
| 4 | Loss on Drying | Not more than 5.0 % w/w | 2.47 | Gravimetry |
| 5 | Total Ash | Not more than 5.0 % w/w | 3.07 | Gravimetry |
| 6 | Bulk Density | As per specification | 0.46 g/mL | Tapped density |
| 7 | Particle Size — through 80 mesh | Not less than 95 % | 97.6 | Sieve analysis |
| 8 | Pesticide Residues | Complies with USP <561> | Complies | GC-MS / LC-MS |
| 9 | Aflatoxins (B1, B2, G1, G2) | Not more than 20 ppb | Less than 2 ppb | HPLC-FLD |
| 10 | Residual Solvents | Complies with ICH Q3C | Complies | Headspace GC |
| 11 | Lead (Pb) | Not more than 3.0 ppm | Less than 0.5 ppm | ICP-MS |
| 12 | Heavy Metals (as Pb) | Not more than 10 ppm | Less than 5 ppm | ICP-OES |
| 13 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 129 cfu/g | IP / USP <61> |
| 14 | Total Yeast & Mould Count | Not more than 100 cfu/g | 5 cfu/g | IP / USP <61> |
| 15 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 16 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
3. Declaration
This document sets out the standard specification for Tribulus Terrestris Extract 40% Saponins 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