Batch Certificate of Analysis
Comprehensive lot-specific CoA specifying assay, botanical identity, particle size, bulk density, loss on drying, and total ash content.
International procurement executives face persistent supply risks: discrepancies between label specifications and analytical results, unverified botanical origins, and unexpected customs detentions due to pesticide or ethylene oxide residues.
At SV Botanica, quality is not a retrospective check; it is engineered into our supply chain. Every commercial batch is accompanied by an immutable, batch-specific analytical dossier. We manufacture exclusively via GMP and ISO-certified infrastructure, operating under DGFT, APEDA, and FSSAI central oversight to ensure seamless compliance for US FDA FSVP and European Union port authorities.
Every commercial export consignment ships with comprehensive analytical and regulatory documentation to facilitate immediate incoming release at your manufacturing facility.
Comprehensive lot-specific CoA specifying assay, botanical identity, particle size, bulk density, loss on drying, and total ash content.
Quantitative verification using calibrated HPLC, GC-MS, or UV-Vis for standard active markers including withanolides, curcuminoids, and piperine.
Total heavy metals and individual quantification of Lead (Pb), Cadmium (Cd), Mercury (Hg), and Arsenic (As) by ICP-MS to USP <2232> limits.
Stringent screening for Total Plate Count, Yeast & Mould, and absolute absence of pathogens including Salmonella, E. coli, and S. aureus.
Extensive screening against 400+ compounds, verified against EU Regulation (EC) No 396/2005 MRLs and USP <561> thresholds.
Targeted quantification of ETO and 2-chloroethanol down to 0.02 mg/kg, ensuring zero border rejections under Regulation (EU) 2019/1793.
Safety Data Sheets (GHS-compliant), TSE/BSE-free statements, non-irradiated declarations, and allergen/GMO non-presence certificates.
Halal, Kosher, USDA NOP / EU Organic documentation on applicable products, backed by APEDA-certified country of origin documentation.
Our end-to-end chain of custody ensures that every lot meets our documented parameters before dispatch from India.
Agronomic sourcing from established Indian growing regions. Species verification at harvest to eliminate wild adulteration.
Raw biomass is quarantined for botanical identification via HPTLC/macroscopy, foreign matter, and moisture screening.
Extraction with food-grade solvents in ISO/GMP facilities adhering to closed-loop parameter logs and validated SOPs.
Internal release testing followed by mandatory verification through third-party ISO 17025 accredited analytical laboratories.
Final release and sealing under controlled ambient conditions upon completion of phytosanitary and export certification.
Trust is rooted in objective validation. All third-party test data are derived from laboratories accredited under NABL (International Laboratory Accreditation Cooperation - ILAC mutual recognition), ensuring global data equivalence.
Test protocols follow international criteria recognized directly by the US FDA, European Food Safety Authority (EFSA), and UK FSA.
ICP-MS for sub-ppb heavy metals, LC-MS/MS for ultra-trace pesticides, and calibrated HPLC with diode array detectors for exact active marker assays.
We welcome third-party pre-shipment sampling and testing via globally chosen providers including Eurofins, SGS, Intertek, or TÜV SÜD prior to container loading.
Every commercial batch conforms to defined pharmacopoeial baseline thresholds. Finished lot limits are confirmed in the product-specific technical dossier.
| Test Parameter | Analytical Methodology | Standard Release Specification |
|---|---|---|
| Active Marker Assay | HPLC / UV-Vis (Monograph Aligned) | Declared marker content guaranteed (e.g., Curcuminoids ≥ 95.0%, Withanolides ≥ 5.0% by HPLC). |
| Total Heavy Metals | ICP-MS (USP <2232> / EP 2.4.8) | NMT 10.0 ppm |
| Lead (Pb) | ICP-MS | NMT 0.5 ppm to 1.0 ppm (compliant with EU Reg 2023/915) |
| Cadmium (Cd) | ICP-MS | NMT 0.5 ppm to 1.0 ppm (botanical category dependent) |
| Mercury (Hg) | ICP-MS | NMT 0.1 ppm |
| Arsenic (As) | ICP-MS | NMT 1.0 ppm |
| Pesticide Residues | GC-MS/MS & LC-MS/MS | Compliant with Regulation (EC) No 396/2005 & USP <561> |
| Ethylene Oxide (ETO) | GC-MS/MS (Sum of ETO + 2-CE) | < 0.05 mg/kg (Compliant with Regulation (EU) 2019/1793) |
| Total Aerobic Microbial Count | USP <2021> / EP 2.6.12 | NMT 1,000 CFU/g to 10,000 CFU/g |
| Yeast and Moulds | USP <2021> / EP 2.6.12 | NMT 100 CFU/g |
| Bacterial Pathogens | USP <2022> / EP 2.6.13 | Salmonella spp., E. coli, and S. aureus: Absent in 10g / 25g |
Our processing partners and export operations maintain current certifications, ensuring rigorous international compliance and full audit-readiness.
Our regulatory and quality team is led by qualified analytical chemists and pharmacognosy specialists who review client specifications, audit certificates, and ensure all release documentation matches your internal regulatory criteria.
Clear guidance regarding analytical validation, laboratory accreditations, and regulatory support for global imports.
Every commercial shipment includes a batch-specific Certificate of Analysis (COA) along with HPLC or UV-Vis standardisation, heavy-metals, microbial and pesticide-residue reports. Allergen, GMO, organic, Halal and Kosher documentation is available on request.
Yes. We provide a representative COA, standardisation certificate and heavy-metals report at the sample evaluation stage, before any commercial order commitment, so your QC team can validate compliance before committing to volume.
Yes. Every COA and test report we provide is specific to the production batch being shipped. We do not provide generic or averaged reports.
Raw materials undergo identity verification and assay testing at intake, followed by in-process checks and finished-batch testing before release from the facility.
Yes. Products are tested for heavy metals by ICP-MS and screened for pesticide residues against USP, EP and EU MRL limits (Regulation 396/2005) as applicable to the destination market.
We source from GMP and ISO certified facilities and hold FSSAI registration and APEDA certification as an exporter, with USDA Organic, EU Organic, Halal and Kosher supply available for selected product lines.
Third-party testing is conducted at NABL-accredited laboratories (India's equivalent of ISO 17025). Buyers requiring specific international labs such as Eurofins, SGS or Intertek can arrange independent pre-shipment testing as part of the purchase process.
Standard shelf life is 24 months from date of manufacture for herbal extracts and nutraceutical ingredients, and 18–24 months for oleoresins and natural oils, when stored cool, dry and away from direct light. The COA states the manufacturing and best-before dates.
Several ingredients in our range have Novel Food status in the EU. We can advise on the regulatory status of specific ingredients and provide the supply documentation required for Novel Food applications. Please specify your target market and intended use in your enquiry.
Validate our analytical chemistry before making commercial purchasing commitments. Speak directly with our export regulatory specialists today.