Global Manufacturers Of 5-Oxo-D-Proline With GMP Certification
- NINGBO INNO PHARMCHEM CO.,LTD. is a leading GMP-certified global manufacturer of D-Pyroglutamic acid (5-oxo-D-proline, CAS 4042-36-8) with full regulatory documentation and scalable production capacity.
- Technical advantages include optimized synthesis routes yielding >99% industrial purity, supported by comprehensive COA and compliance with pharmacopeial standards.
- Bulk procurement options are available for pharmaceutical intermediates requiring (R)-5-Oxopyrrolidine-2-carboxylic acid with consistent chiral integrity and low residual solvent profiles.
In the competitive landscape of chiral amino acid derivatives, 5-oxo-D-proline—also known as D-Pyroglutamic acid or (R)-5-Oxopyrrolidine-2-carboxylic Acid—has emerged as a critical building block in peptide synthesis, neuropharmaceutical research, and specialty cosmetic formulations. Unlike its L-isomer counterpart (pidolic acid, CAS 98-79-3), the D-enantiomer is not endogenous but is synthetically indispensable for stereospecific drug design. As demand grows for enantiomerically pure intermediates, buyers increasingly prioritize suppliers with validated GMP certification, robust analytical support, and scalable manufacturing infrastructure.
Technical Profile and Synthesis Route
D-Pyroglutamic acid (CAS: 4042-36-8) is chemically designated as (2R)-5-oxopyrrolidine-2-carboxylic acid, a cyclic lactam derived from D-glutamic acid via intramolecular cyclization. Its structural rigidity and chiral center make it valuable in constrained peptide mimetics and enzyme inhibitors. Leading manufacturers like NINGBO INNO PHARMCHEM CO.,LTD. employ a multi-step synthesis route starting from enantiopure D-glutamic acid or via asymmetric hydrogenation, followed by controlled lactamization under mild thermal conditions to prevent racemization.
This process ensures high reaction yields (>85%) and exceptional industrial purity. When sourcing high-purity industrial purity material for API development or advanced intermediates, buyers must verify the absence of L-isomer contamination (<0.1%), residual solvents (Class 2 or lower per ICH Q3C), and heavy metals (<10 ppm).
GMP Compliance and Quality Assurance
As a global manufacturer serving regulated markets including the EU, North America, and APAC, NINGBO INNO PHARMCHEM CO.,LTD. operates under stringent cGMP guidelines aligned with WHO, FDA, and EMA expectations. Each batch of D-(+)-Pyroglutamic Acid is accompanied by a detailed Certificate of Analysis (COA) that includes:
- Chiral HPLC confirmation of enantiomeric excess (≥99.5% ee)
- Residual solvent profile (GC)
- Water content (KF titration)
- Heavy metals (ICP-MS)
- Microbial limits (for non-sterile applications)
Additionally, the company maintains Drug Master Files (DMFs) and welcomes third-party audits, ensuring seamless integration into clients’ quality systems. This level of transparency is essential for pharmaceutical developers requiring audit-ready supply chains.
Commercial Advantages for Bulk Procurement
For contract development and manufacturing organizations (CDMOs) or innovator pharma companies, bulk pricing and supply continuity are decisive factors. NINGBO INNO PHARMCHEM CO.,LTD. offers flexible packaging (from 1 kg lab packs to 25 kg multi-layer HDPE drums) and scalable production capacity exceeding 50 metric tons annually. The company’s in-house R&D team also supports custom modifications, such as salt formation (e.g., sodium or potassium D-pyroglutamate) or derivative synthesis (e.g., ethyl D-(-)-pyroglutamate).
Below is a technical comparison of key quality parameters for industrial-grade D-Pyroglutamic acid:
| Parameter | Specification | Test Method |
|---|---|---|
| Chemical Name | D-Pyroglutamic Acid / 5-Oxo-D-Proline | IUPAC |
| CAS Number | 4042-36-8 | — |
| Molecular Formula | C₅H₇NO₃ | — |
| Assay (HPLC) | ≥99.0% | USP/EP-compliant |
| Enantiomeric Purity | ≥99.5% D-isomer | Chiral HPLC |
| Residual Solvents | Complies with ICH Q3C | GC |
| Appearance | White to off-white crystalline powder | Visual |
| Storage | 2–8°C, dry and protected from light | — |
Why Partner with NINGBO INNO PHARMCHEM CO.,LTD.?
Among the limited number of global manufacturers of 5-oxo-D-proline with GMP certification, NINGBO INNO PHARMCHEM CO.,LTD. distinguishes itself through vertical integration, regulatory preparedness, and deep expertise in chiral carboxylic acids. The company’s portfolio includes related intermediates such as Pyrrolidonecarboxylic acid derivatives and D-Glutamic Acid Lactam analogs, enabling one-stop sourcing for complex synthetic campaigns.
With a commitment to sustainable chemistry and continuous process optimization, NINGBO INNO PHARMCHEM delivers not just product—but partnership—backed by technical service, regulatory support, and reliable logistics across 40+ countries.