QUALITY ASSURANCE

≥99.97% Purity. Verified.

Every compound in The Egyptian Collection undergoes rigorous analytical testing at Bachem AG, Switzerland — the global leader in pharmaceutical-grade peptide synthesis since 1971.

VIEW COA SPECIFICATIONS TESTING METHODOLOGY
🔬 ≥99.97% HPLC Purity · 🇨🇭 Bachem AG, Switzerland · ✓ cGMP / FDA / Swissmedic · 🧬 Endotoxin-Free <0.25 EU/mg · 📄 COA Every Batch
OUR MANUFACTURER

Bachem AG — Swiss Manufacturing Excellence

Founded in 1971, Bachem AG operates state-of-the-art production facilities in Bubendorf, Switzerland, with over five decades of expertise in peptide synthesis. Their vertically integrated manufacturing process encompasses proprietary amino acid production, solid-phase and solution-phase peptide synthesis, chromatographic purification, lyophilization, and comprehensive analytical quality control.

All production is conducted under current Good Manufacturing Practice (cGMP) guidelines with FDA, Swissmedic, and EMA regulatory oversight. Bachem serves over 80% of all peptide-based drug development programs worldwide.

1971 Founded in Switzerland
50+ Years of Expertise
80% Global Peptide Drug Programs
Swiss Laboratory

Bachem AG Facility — Bubendorf, Switzerland

The Manufacturing Process

From raw amino acids to certified research compound — every step under Swiss pharmaceutical-grade control.

01

Amino Acid Synthesis

Proprietary production of ultrapure building blocks in-house — no third-party sourcing.

02

Peptide Assembly

Solid-phase and solution-phase synthesis under strictly controlled clean-room environments.

03

HPLC Purification

Chromatographic purification removes impurities to achieve ≥99.97% purity levels.

04

Lyophilization

Freeze-drying preserves peptide stability for long-term storage and transport integrity.

05

Analytical QC

HPLC, MS, LAL endotoxin, amino acid analysis — every batch independently verified.

06

COA Issuance

Certificate of Analysis documenting all test results issued for every production batch.

Certificate of Analysis Specifications

Every batch of every compound in The Egyptian Collection is tested against the following specifications. Certificates of Analysis are available for download on each product page.

Test Parameter Method Specification
Purity HPLC (C18 Reverse Phase) ≥99.97%
Identity Mass Spectrometry (ESI-MS) Confirmed ± 0.1 Da
Endotoxin LAL (Kinetic Turbidimetric) <0.25 EU/mg — Endotoxin-Free
Residual Solvents GC Headspace ICH Q3C Compliant
Water Content Karl Fischer Titration ≤5.0%
Amino Acid Analysis Ion-Exchange Chromatography Within ±10% of theoretical
Appearance Visual Inspection White to off-white lyophilized powder
Regulatory Compliance Facility Certification cGMP / ICH Q7 / FDA / Swissmedic / EMA

Testing Methodology

HPLC Analysis

High-Performance Liquid Chromatography separates, identifies, and quantifies each component in a peptide sample using C18 reverse-phase columns. Our ≥99.97% purity threshold means that ≥99.97% of the measured compound is the intended molecule, with ≤0.03% impurities. This exceeds industry-standard thresholds by a significant margin.

Mass Spectrometry (ESI-MS)

Electrospray Ionization Mass Spectrometry confirms the molecular weight and identity of each peptide with precision of ±0.1 Daltons. This ensures the compound matches its intended amino acid sequence and structure — providing definitive identification beyond chromatographic purity alone.

Endotoxin Testing (LAL)

Limulus Amebocyte Lysate testing using kinetic turbidimetric methodology confirms endotoxin levels below 0.25 EU/mg — classified as endotoxin-free under USP <85> guidelines. This is critical for research applications requiring sterile-grade compounds free of bacterial contamination.

Residual Solvent Analysis

Gas Chromatography headspace analysis screens for residual manufacturing solvents. All compounds meet ICH Q3C(R8) guidelines for residual solvents in pharmaceutical products, ensuring no harmful solvent residues remain after the purification and lyophilization process.

How to Read a Certificate of Analysis

Product Identification

The top section identifies the compound by name, molecular formula, molecular weight, catalog number, and batch/lot number. This is your reference for matching the COA to the specific vial you received.

Purity & Identity Results

The core of the COA. Look for the HPLC purity percentage (should read ≥99.97%) and the MS identity confirmation (confirmed molecular weight matching the target compound). These two results together verify both purity and identity.

Safety Parameters

Endotoxin level (LAL test result, reported in EU/mg), residual solvents (ICH Q3C compliance), and water content (Karl Fischer %). These parameters confirm the compound is safe for laboratory research use and free of manufacturing contaminants.

Dates & Signatures

Every COA includes the manufacture date, test date, and expiry/retest date. The document is reviewed and signed by the Quality Control department of the manufacturing facility. These dates are critical for ensuring compound integrity within the stated shelf life.

COA documents are available for download on each product page. For batch-specific requests, contact support@sphinxpeptides.com with your order number and batch number.

The Sphinx Standard vs. Industry Average

Parameter
Sphinx Peptides
Purity Standard
≥99.97% HPLC
Manufacturer
Bachem AG, Switzerland
Endotoxin Testing
<0.25 EU/mg (Endotoxin-Free)
cGMP Certified
✓ FDA / Swissmedic / EMA
COA per Batch
✓ Full Analytical Report
Identity Verification
✓ ESI-MS Confirmed

Explore The Egyptian Collection

12 research-grade peptides. Swiss-manufactured. ≥99.97% verified purity. COA documented.

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This product is intended for in-vitro research and laboratory use only. Not for human consumption. Not intended to diagnose, treat, cure, or prevent any disease.