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100GC® Spiroplasma citri (Illustration similar or symbolic)
Illustration similar or symbolic

100GC® Spiroplasma citri

100GC® Mycoplasma Standards are non-infectious reference materials for matrix-specific validation of PCR-based mycoplasma tests.
- Compliant with EP 2.6.7 (12.2)
- Ready-to-use 100 GC/ml standards for reliable matrix-specific validation
- Non-infectious and regulatory safe

Cat. No.: 104-9001

€390.00
Tax excluded excl. Shipping costs

Files to download:

SDS.pdf
Flyer.pdf
Poster.pdf
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If you want your order to be delivered to these countries please visit our American store: https://minervabiolabs.us
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Product Description

Mycoplasmas represent one of the greatest contamination risks in cell cultures and in biopharmaceutical production (e.g. ATMPs). European Pharmacopoeia (EP) 2.6.7 requires a validated test method for the release of such products, capable of detecting both culturable and non-culturable mycoplasmas. Nucleic acid amplification techniques (NAT) have become the new gold standard, as they reliably detect both forms. The previously applied sensitivity limit of 10 CFU/ml was based on classical culture methods.

With the new edition 12.2 of EP 2.6.7, the requirements change: For PCR methods, a sensitivity limit of less than 100 genome copies/ml (GC/ml) is introduced. This PCR-appropriate unit is considered practical for PCR laboratories and has long been expected as a standard for determining the detection limit.

Our 100GC® Mycoplasma Standards are specifically designed to meet these new requirements. They are non-infectious and therefore safe to handle, titrated to 100 GC, and comply with the new regulatory guideline for NAT standards. The standards are lyophilized and ready to use after reconstitution. In addition, the standards can be used as an external positive control with defined concentration, fulfilling all new regulatory requirements.

Optionally, 10 CFU/ml standards remain available for comparability with classical culture methods.

Specification

Species Spiroplasma citri
Application Mycoplasma detection
Use cases
  • Method validation according to EP 2.6.7
  • External positive control for mycoplasma testing
  • QC batch release and routine testing
Contents
  • 3 vials each containing 100 GC (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Compliance EP 2.6.7
Required equipment
& consumables
  • PCR thermal cycler
  • PCR reaction tubes
  • Centrifuge for 1.5 mL PCR tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration after
reconstitution		 100 GC/ml
Sample type RNA-containing DNA standard
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See expiration date on package

More Available Species

Cat. No. 104-1001: Mycoplasma arginini
Cat. No. 104-2001: Mycoplasma orale
Cat. No. 104-3001: Mycoplasma gallisepticum
Cat. No. 104-4001: Mycoplasma pneumoniae
Cat. No. 104-5001: Mycoplasma synoviae
Cat. No. 104-6001: Mycoplasma fermentans
Cat. No. 104-7001: Mycoplasma hyorhinis
Cat. No. 104-8001: Acholeplasma laidlawii
Cat. No. 104-1101: Mycoplasma salivarium