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Reference Materials for Pharmaceutical Testing

Our comprehensive experience in creating quality pharmaceutical standards will help you to comply with the guidelines set by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) to provide accurate, quantifiable results for the metal analysis in drugs, pharmaceutical substances and raw materials.

  • Certified for multiple analytical methods (e.g. EU. Ph, JP, USP, ICH, FDA, AOAC, etc.)
  • COA includes purity and certified values for a variety of analytical techniques
  • Accurate and robust chemical and microbiological certified reference materials
  • Neat and solution based reference materials available
  • Custom reference material manufacturing capabilities under ISO 17034. Learn More


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Pharmaceutical Standards

Complete line of compendial strains for USP 51 and USP 61/62

Qualitative Reference Cultures for USP 51 and USP 61/62

Manufactured from USP specified pure organism strains using media and procedures conforming to USP specifications. These CRMs are manufactured no more than 2 passages from the primary culture.

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Microorganism

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SKU: 61-0032

S. aureus

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-0012

E. coli

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-00054

C. albicans

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-00053

A. brasiliensis

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-00031

S. enterica

  • CCL
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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-0003

B. subtilis

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-00029

S. enterica abony

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: 61-00026

P. aeruginosa

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  • Brand NSI
  • Raw Material <2 passages from primary culture
  • Certification Cultural based enumeration
SKU: PHMIX2C

Residual Solvents Mixture - Class IIC

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  • Brand NSI
  • Raw Material >95% min; as available
  • Certification Mass Balance; w/Analytical confirmation
SKU: PHMIX2B

Residual Solvents Mixture - Class IIB

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  • Brand NSI
  • Certification Mass Balance; w/Analytical confirmation
  • Raw Material >95% min; as available
SKU: PHMIX2A

Residual Solvents Mixture - Class IIA

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  • Brand NSI
  • Certification Mass Balance; w/Analytical confirmation
  • Raw Material >95% min; as available
SKU: PHMIX1

Residual Solvents Mixture - Class I

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  • Brand NSI
  • Raw Material >95% min; as available
  • Certification Mass Balance; w/Analytical confirmation
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