Pharmaceutical Reference Materials

LEANGENE partners with LGC Standards, a division of the LGC Group, to deliver LGC Pharmaceutical Reference Materials to the pharmaceutical industry in Jordan.

 

Extensive testing is required prior to obtaining approval to place a pharmaceutical drug on the market. We provide over 5,000 pharmaceutical impurity reference materials manufactured by LGC Standards the global leader in the production and distribution of reference materials for the pharmaceutical industry.

LGC pharmaceutical impurity standards are supplied with one of the most extensive certificate of analysis (CofA), giving you greater analytical flexibility and certainty. LGC Standards provides supplementary products such as secondary reference standards which are compared to USP, EP or BP and accompanied with an advanced certificate of analysis.

LGC impurity and primary reference standards fulfil ICH, FDA, EMA and other regulatory body requirements. Using LGC‘s reference standards ensures that you are well equipped and prepared for all audits or inspections.

Broad range of over 10,000 reference standards for impurities, APIs and excipients.

Pharmaceutical Impurities 

Impurities

Impurity reference materials help you to detect, identify, quantify and qualify impurities in a drug substance in accordance with the ICH guidelines (Q3A, Q3B, Q3D and Q7).

LGC impurity standards under the Mikromol™ brand are of the highest purity, and come with the most extensive certificate of analysis on the market, affording you maximum analytical certainty.

Primary Reference Standards

Primary RF

LGC produces and certifies one of the largest collections of primary reference standards under Mikromol™ API product range. They fulfills all ICH, FDA and other regulatory body requirements for universal qualitative and quantitative pharmaceutical quality control, as well as all the relevant metrological requirements from ISO guidelines.

Pharmacopoeial/ Monograph Standards

Pharmacopoeial Standards

LGC supplies over 10,000 pharmaceutical reference standards from all relevant industry suppliers including the world's Pharmacopoeias. A pharmacopoeial reference standard is a reference standard for active ingredients, excipients and impurity substances established under the aegis of and approved by the relevant Pharmacopoeia, such as USP, EP, BP and JP.

Pharmaceutical Proficiency Testing, PHARMASSURE

Pharmaceutical PT

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UKAS Accredited Proficiency Testing Scheme

A comprehensive range of chemical, microbiological and sterility test materials for pharmaceutical laboratories.

  • Basic/advanced chemical testing, HPLC and elements analysis, dissolution, tablet and solution testing.
  • Low level microbial inoculum for enumeration/identification of a single culture by membrane filtration.
  • High level microbial inoculum for enumeration/detection of a mixed culture.
  • Sterility test materials which may or may not contain low level microorganism for sterility and indentification.

 

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LEANGENE For Medical & Electronic Supplies

Makkah Al Mukarrama St. | Al Husseni Complex | Bld no. 147 | 5th Floor | Amman-Jordan |

T:+962-6-46-55401 | F:+962-6-46-55402 

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