Bulk Supply Fmoc-Gly-OH

Product Definition

Fmoc-Gly-OH (N-α-Fmoc-glycine) is a high-purity, Fmoc-protected amino acid derivative designed for cGMP-compliant solid-phase peptide synthesis (SPPS), delivering consistent batch-to-batch quality to peptide manufacturers and research institutions producing GLP-1 analogues, therapeutic peptides, and diagnostic reagents at production scale.

Core Selling Points

Purity ≥ 99.0% (HPLC): Minimizes difficult deletions and impurities during peptide chain elongation, directly improving final peptide yield and reducing downstream purification cost.
Optical Purity (Enantiomeric Excess) ≥ 99.5%: Prevents D-isomer incorporation into peptide sequences, a critical control point for therapeutic peptide quality and regulatory compliance.
Chromatographic Purity: Single Impurity ≤ 0.1%: Helps peptide manufacturers streamline QC release testing and reduces the risk of failing GMP release specifications.
Consistent Residual Solvents Meeting ICH Q3C Guidelines: Eliminates solvent-related batch failures and simplifies solvent validation documentation for GMP manufacturing.
Scalable Supply from Research Grade to Multi-Hundred-Kilogram Quantities: With dedicated production lines and rapid turnaround, it supports seamless tech-transfer from process development to commercial manufacturing without re-qualification.

Detailed Specification Sheet

Parameter	Value	Supplementary Notes
Product Name	Fmoc-Gly-OH (N-α-Fmoc-glycine)	CAS Number: 29022-11-3
Molecular Formula	C17H15NO4	Molecular Weight: 297.31 g/mol
Appearance	White to off-white crystalline powder	Visual inspection per internal SOP
Assay (HPLC, anhydrous basis)	≥ 99.0%	Area normalization method
Enantiomeric Purity	≥ 99.5% ee	Chiral HPLC analysis
Melting Point	174°C – 178°C	Differential Scanning Calorimetry
Loss on Drying	≤ 0.5%	105°C, 3 hours
Residual Solvents	Meets ICH Q3C limits	Gas chromatography headspace analysis
Heavy Metals	≤ 10 ppm	ICP-MS
Bulk Density	0.35 – 0.55 g/mL	Tapped density method
Standard Packaging	1 kg, 5 kg, 25 kg (aluminum foil bags / fiber drums)	Custom packaging with nitrogen purge available
Storage Conditions	2°C – 8°C, sealed, protected from light and moisture	Stability data supports 24-month shelf life
Regulatory Documentation	COA, HPLC chromatogram, MSDS, TDS	GMP compliance documents available upon request

Specifications are based on supplier's standard Certificate of Analysis (COA); each batch is individually tested.

Intended Use Cases

Custom Peptide Manufacturers: For multi-step SPPS production of peptide APIs requiring Fmoc-Gly-OH with strict impurity profiles to meet FDA or EMA filing standards.
CDMO Process Scale-Up Teams: For the scale-up of peptide synthesis from gram to multi-kilogram scale, where bulk supply consistency and low batch-to-batch variation directly affect process reproducibility.
Research Institutions Developing Peptide Therapeutics: When researchers need a reliable Fmoc-Gly-OH source for structure-activity relationship (SAR) studies with sufficient quantity for in vivo efficacy studies.
Diagnostic Reagent Companies: For GMP-compliant production of peptide-based diagnostic antigens or reagents, where low racemization and high chemical purity are essential.

Frequently Asked Questions

What is the lead time for bulk orders of Fmoc-Gly-OH?For quantities up to 100 kg, standard lead time is 5-7 working days after purchase order confirmation; larger volumes are scheduled based on confirmed forecast.

Can you provide GMP-compliant documentation for regulatory filing?Yes, we supply a comprehensive documentation package including COA, HPLC chromatograms, residual solvent data, stability summary, and manufacturing flow chart upon request.

How do you ensure batch-to-batch consistency in large-scale production?Our process uses a fixed, validated synthetic route with strict in-process control limits, and every batch undergoes full QC testing per our approved specification before release.

What packaging options are available to protect the product during transit?Standard packaging is 25 kg multilayer aluminum foil bags with nitrogen flushing inside fiber drums; customized packaging to suit your production line handling can also be arranged.

Is Fmoc-Gly-OH stable under room temperature shipping conditions?While recommended storage is 2°C – 8°C, the product is stable at ambient temperature for up to 4 weeks during transit without degradation; this has been confirmed by transport simulation stability studies.

Do you support DMF filing with the FDA?Yes, the Drug Master File (DMF) is available for registration purposes, and we promptly support our customers' drug applications with necessary technical assistance.

Can Fmoc-Gly-OH be supplied in pre-weighed bags for direct dissolution use?We can supply pre-weighed single-use packaging from 10 g to 1 kg upon request to minimize contamination risk in your weighing area.

What is your quality management standard?Our production facility operates under an ISO 9001-certified quality management system, and all GMP-grade products are manufactured under strict quality control standards.

Differentiation Summary

Compared to standard Fmoc-Gly-OH grades from catalog suppliers, this product is optimized specifically for bulk, regulated manufacturing environments. The technical file includes detailed enantiomeric purity data, a comprehensive residual solvent profile per ICH Q3C, and multi-year stability documentation—datasets commonly incomplete for low-cost commodity suppliers. The full traceability from raw materials to finished goods, combined with flexible packaging options and dedicated production line scheduling, makes it a preferred choice for manufacturers prioritizing supply security and regulatory readiness. It is best suited for peptide contract manufacturers, API producers, and R&D groups who require documented quality with minimal qualification overhead.