1. What pharmacopeial standard does your SSG Type A meet?
Our Sodium Starch Glycolate (Type A) complies with USP 43-NF 38 specifications. Each batch is manufactured under GMP conditions and includes complete COA, TSE/BSE statements, and DMF support documentation for FDA/EMA submissions.
2. What is the typical assay range and sodium glycolate content?
Specification: Assay 2.8–4.2%, Sodium Glycolate ≤2.0%. Recent batch analysis shows 3.0% assay and <2.0% sodium glycolate, ensuring consistent superdisintegrant performance without impacting API stability.
3. Is this suitable for both direct compression and wet granulation?
Yes. Type A grade exhibits fast swelling in contact with water, making it ideal for immediate-release tablets, ODTs, and capsules via direct compression or wet granulation processes at typical usage levels of 2–8% w/w.
4. What are your microbial limits and heavy metal controls?
Microbial: ≤1,000 cfu/g total plate count, ≤100 cfu/g yeast/mold, absent E. coli/Salmonella per 1g. Iron: ≤0.002%. Our per-batch testing ensures compliance for oral dosage forms in regulated markets.
5. Can I get a technical sample and COA before ordering?
Absolutely. We provide 100g R&D samples with complete Certificate of Analysis (COA), Technical Data Sheet (TDS), and MSDS within 24 hours. Contact us for formulation-specific guidance.
6. What is your MOQ, lead time, and packaging?
MOQ: 25 kg (1 bag) for samples; commercial orders start at 100 kg
Lead Time: 7–10 days for samples; 2–3 weeks for bulk orders
Packaging: 25 kg/bag with PE liner; 20 kg fiber drums available
All shipments include full regulatory documentation.
Need formulation support or bulk pricing? Contact our excipient specialists today for immediate assistance.