Steroid & Raw API Powder Screening
Quantitative Potency Assay, Related Substances Identification, Melting Point Determination, and Residual Solvent Profiling (GC-MS) for Bulk Chemical Powders and Active Pharmaceutical Ingredients.
Comprehensive Verification for Bulk Raw Powders
Bulk raw materials, steroid hormone intermediates, selective androgen receptor modulators (SARMs), and reference small molecules require rigorous analytical verification before compounding or research usage.
Our Steroid & Raw API Screening Panel couples reverse-phase liquid chromatography (HPLC-UV/DAD) with gas chromatography-mass spectrometry (GC-MS) and physical property testing. This multi-technique approach confirms chemical identity, measures exact active percentage (assay content), detects synthesis precursors or adulterants, and identifies harmful residual manufacturing solvents (such as dichloromethane, methanol, hexane, and benzene).
Analytical Modules Included in API Screening
Comprehensive examination of chemical purity, physical characteristics, and volatile impurities.
Quantitative Potency Assay
Comparison of response factor against verified primary reference standards to establish true potency (e.g. 98.6% active API content w/w).
Melting Point & Phase Transition
Digital optical capillary melting point determination (±0.1°C resolution) verifying crystalline structure and detecting polymorphic variations.
Headspace GC-MS Solvent Screening
Screening for 28 common processing solvents conforming to ICH Q3C limits (ppm detection of methanol, acetone, THF, ethanol, ethyl acetate).
Adulterant & Cutting Agent Screen
Exclusion screening against common fraudulent cutting agents, starches, lactose, paracetamol, caffeine, or undeclared structural analogues.
Screening Capabilities Matrix (SOP-API-04)
| Category | Target Compounds Tested | Primary Analytical Methods | Regulatory Guideline |
|---|---|---|---|
| Anabolic Hormones & Esters | Testosterone, Nandrolone, Trenbolone, Drostanolone, Boldenone esters | RP-HPLC / UV-DAD @ 240nm / 254nm | USP <621> / EP Monographs |
| Oral Compounds & SARMs | Oxandrolone, Stanozolol, RAD-140, LGD-4033, MK-677, Enclomiphene | RP-HPLC C18 / Orbitrap Exact Mass | In-house validated SOP |
| Residual Solvents | Methanol, Isopropanol, Dichloromethane, Hexane, Toluene, Acetone | Agilent 7890B GC / 5977B MSD (Headspace) | ICH Guideline Q3C (R8) |
| Physical Verification | Appearance, bulk color, melting range, optical rotation $[\alpha]_D$ | Optimelt Digital Melting / Rudolph Polarimeter | USP <741> / USP <781> |
Submission Guidelines for Raw APIs
- Sample Quantity: 20 – 50 mg dry raw powder, or 1.0 mL neat solution in a sealed micro-centrifuge tube or amber glass vial.
- Packaging: Double-bag powder samples in polyethylene ziplock pouches inside padded bubble mailers.
- Blind Coded Orders: Samples may be submitted with private batch codes (e.g. "API-Batch-99") under our strict double-blind guarantee.
- Reporting: Detailed Certificate of Analysis with HPLC chromatogram, GC-MS solvent table, and active weight percentage.