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Oct . 19, 2025 10:50 Back to list

Pharma Intermediates | High Purity, GMP, Custom Synthesis



What’s Really Happening in pharma intermediates for GLP‑1 Peptides

If you’ve tried to source GLP‑1 peptide building blocks lately, you’ll know the market is crowded—and noisy. To be honest, buyers are juggling specs, audits, and delivery risks all at once. I spent part of last quarter speaking with teams from Shijiazhuang to Basel, and one product kept popping up in conversations: High Purity Peptides Powder Semaglutide Liraglutide CAS 204656-20-2. It’s a mouthful, but for teams scaling R&D and pilot batches, it’s become a practical choice.

Pharma Intermediates | High Purity, GMP, Custom Synthesis

Industry trends and where this fits

GLP‑1 analogs are surging, which has pushed demand for high-purity pharma intermediates suitable for preclinical and early clinical development. Lead times matter (a lot), and so do dependable test data. Teams tell me they want flexible payments, compliant customs handling, and a vendor who doesn’t vanish after shipment—surprisingly rare.

Product snapshot and specs

Origin: Room 1727, Dongyiyuan International, Xinyi Road, Shijiazhuang, Hebei. Payments supported: Bitcoin, Western Union, T/T, Moneygram, PayPal. The supplier states they use special lines for customs clearance and door-to-door delivery—claimed as 100% safe shipping; in practice, buyers should verify local compliance and import rules.

Parameter Specification (≈, real-world use may vary)
Name High Purity Peptides Powder Semaglutide/Liraglutide (GLP‑1 series)
CAS Primary ≈ 204656-20-2 (Liraglutide); Semaglutide variants on request
Purity (HPLC) ≥ 98.0% (USP <621> method adaptation)
Identity LC–MS/MS match to reference (±0.5 Da)
Residual solvents Per ICH Q3C; typical ND–within limits by GC
Heavy metals ICP‑MS per ICH Q3D; As, Cd, Hg, Pb within PDE
Water (KF) ≤ 5.0%
Shelf-life ≈ 24 months at −20°C (sealed, desiccated, light-protected)

Process flow (how it’s made)

Materials: protected amino acids (Fmoc), tailored lipid moieties (e.g., C16/C18), coupling reagents (HATU/HBTU), low‑ash resins.
Methods: SPPS with controlled deprotection cycles, TFA cleavage, preparative RP‑HPLC, lyophilization, nitrogen‑purged packaging.
Testing standards: ICH Q7‑aligned QA, HPLC per USP <621>, residual solvents per ICH Q3C, elemental impurities per ICH Q3D, bioburden/endotoxin as required by phase.
Service life: validated stability at −20°C; for short-term handling 2–8°C recommended.
Industries: pharma, biotech, CROs/CDMOs, advanced academics (non‑human use unless appropriately qualified).

Applications, customization, and real-world feedback

Typical uses: method development, formulation screening, tox batches, comparability studies. Customization: alternative acylation (e.g., semaglutide C18), spacer variants, impurity standards, mg‑to‑kg scale-ups. Many customers say the COA alignment with in‑house HPLC is “boringly consistent,” which—let’s be honest—is exactly what you want from pharma intermediates.

Customer note: a mid‑size EU developer reported purity 98.5% (own HPLC), identity confirmed by ESI‑MS, and batch‑to‑batch RSD < 1.2% across three lots.

Pharma Intermediates | High Purity, GMP, Custom Synthesis

Vendor comparison (quick take)

Vendor Certifications/Docs MOQ Lead time Customization Shipping/Payments
Weimiao Bio (Shijiazhuang) COA, MSDS; ISO9001‑style QMS (verify); ICH Q7 alignment ≈ 10–100 g ≈ 7–15 days High (lipidation, impurities) Bitcoin/WU/T/T/PayPal; door‑to‑door lines
EU‑based Supplier A GMP‑like docs, full audit pathway ≈ 1–10 g ≈ 2–4 weeks Medium Standard courier; bank transfer
India‑based Supplier B COA, DMF support on request ≈ 50 g+ ≈ 2–3 weeks High Courier/sea; LC/T/T

Case study (brief)

A Nordic biotech needed 200 g of liraglutide intermediate with palmitoylation. They received three staggered lots over 12 days; internal QC showed HPLC 98.3–98.7%, endotoxin < 0.25 EU/mg, and solvent levels within ICH Q3C. The kicker: fewer reformulations because the impurity profile stayed stable. It seems that reliable pharma intermediates shave weeks off timelines.

Compliance notes

Use in accordance with local laws; not for human administration unless supplied as qualified API under applicable GMP. Request audit packs, method files, and stability summaries before scale-up.

Authoritative references

  1. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
  2. USP General Chapter <621> Chromatography.
  3. ICH Q3C/Q3D: Residual Solvents and Elemental Impurities Guidelines.
  4. EMA/FDA guidances on peptide APIs and quality documentation (region-specific).
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