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10CFU® Mycoplasma pneumoniae (Illustration similar or symbolic)
Illustration similar or symbolic

10CFU® Mycoplasma pneumoniae

10CFU® Mycoplasma Standards are inactivated, non-infectious, lyophilized mycoplasma particles designed as reference material for product-specific validation of PCR-based mycoplasma testing methods.
- Compliant with EP 2.6.7 (12.2), USP <77>, and JP 18 G3
- Defined concentration of ≤10 CFU/ml, GC:CFU ratio <10
- Suitable for product-specific validation and for use as EPC/EIC

Cat. No.: 105-4001

€429.00
Tax excluded excl. Shipping costs
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Resources

Manual.pdf
Compliance Information.pdf
SDS.pdf
Flyer.pdf
Validation Guide
10CFU® Mycoplasma pneumoniae Validation Guide for 10CFU® Mycoplasma pneumoniae

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Product Description

Validated mycoplasma testing is required for biopharmaceutical products, cell culture-derived products, and ATMPs according to EP 2.6.7, USP <77>, and JP 18 G3.

10CFU® Mycoplasma Standards are non-infectious, inactivated mycoplasma reference standards designed for LOD determination, product-specific validation (“test for inhibitory substances” and “method suitability testing”), and use as external positive control (EPC)/extraction inhibition control (EIC) in NAT-based mycoplasma testing.

Manufactured in accordance with EP 2.6.7 (12.2), the standards are non-infectious, safe to handle and support validated mycoplasma detection according to EP 2.6.7, USP <77>, and JP 18 G3. After reconstitution, defined amounts of the standard are spiked into the relevant product or sample matrix to verify assay sensitivity and demonstrate reliable detection at low contamination levels.

Not sure which mycoplasma standard to choose? Learn how to select the right reference material for validation and routine testing.

Application-Specific Relevance

Mycoplasma pneumoniae is a human-associated mycoplasma species and is phylogenetically related to other clinically relevant human mycoplasmas. The 10CFU® Mycoplasma pneumoniae standard is therefore particularly suitable for risk-based validation of NAT-based mycoplasma testing in human cell culture and biopharmaceutical manufacturing processes.

Specification

Product category 10CFU® Mycoplasma Standards
Species Mycoplasma pneumoniae
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10119
ATCC code 15531
Application NAT-based mycoplasma testing
Application areas
  • Product-specific validation
  • Test for inhibitory substances (EP 2.6.7)
  • Method suitability test (USP <77>)
  • External positive control (EPC/EIC)
Compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤10 CFU (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Required equipment
& consumables
  • PCR reaction tubes
  • Centrifuge for 1.5 ml PCR reaction tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration ≤10 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

More Available Species

Cat. No. 105-1001: Mycoplasma arginini
Cat. No. 105-2001: Mycoplasma orale
Cat. No. 105-3001: Mycoplasma gallisepticum
Cat. No. 105-5001: Mycoplasma synoviae
Cat. No. 105-6001: Mycoplasma fermentans
Cat. No. 105-7001: Mycoplasma hyorhinis
Cat. No. 105-8001: Acholeplasma laidlawii
Cat. No. 105-9001: Spiroplasma citri
Cat. No. 105-1101: Mycoplasma salivarium