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LGC primary standards

If no official standard from a pharmacopoeia exists for a given purpose, primary standards from other sources can be used. For such primary reference standards the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Food and Drug Administration (FDA) demand a reference standard of the highest possible purity and full characterisation. LGC Standards has produced and certified a new range of pharmaceutical primary standards that fulfill ICH, FDA and other regulatory bodies’ requirements for pharmaceutical quality control. Using LGC‘s primary reference standards ensures that you are well equipped and prepared for all audits or inspections. Our primary reference standards are produced under ISO Guide 34, and are filled into vials under argon atmosphere to ensure stability of unopened containers.

The detailed certificate of analysis includes:

Comprehensive identity information

Nuclear magnetic resonance (NMR) spectrum

Infrared spectrum (IR)

Mass spectrometry data (MS)

Detailed purity/assay data

Assay information by accredited technique, qNMR whenever possible Confirmation by orthogonal method, e.g. mass balance For the full range of available substances, please view our primary standards brochure.

For further information or to place an order, please contact us.

Ambroxol Hydrochloride 250 mg LGCQUANT0005.00
Norgestrel 250 mg LGCQUANT0122.00-250
L-Tryptophan 250 mg LGCQUANT0172.00-250
Triamcinolone Acetonide 250 mg LGCQUANT0198.00-250
Meloxicam 250 mg LGCQUANT0246.00-250
Fluoxetine Hydrochloride 250 mg LGCQUANT0256.00-250
Codeine Phosphate Hemihydrate 250 mg LGCQUANT0442.00-250
Clopidogrel Hydrogen Sulphate 250 mg LGCQUANT0455.10-250
Prednisone 250 mg LGCQUANT0482.00-250
Nicotine [for single use] 100 mg LGCQUANT0517.00-100MG
1-[(1R)-1-Phenylethyl]-1H-imidazole-5-carboxylic Acid (Etomidate Acid) 100 mg LGCQUANT1264.04
Cocaine Hydrochloride 250 mg LGCQUANT1345.00-250
Maleic Acid 250 mg LGCQUANT1439.00-250
Paracetamol 250 mg LGCQUANT0042.00
Heroin (Diacetylmorphine) 50 mg LGCQUANT0037.17
Propranolol Hydrochloride 250 mg LGCQUANT0043.00-250
Buprenorphine (K P-III) 250 mg LGCQUANT0120.00
Ropinirole Hydrochloride 250 mg LGCQUANT0331.00
Dexamethasone Acetate 250 mg LGCQUANT0445.00-250
Diphenhydramine Hydrochloride 250 mg LGCQUANT0490.00-250


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