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100CFU® Mycoplasma synoviae

100CFU® Mycoplasma Standards are inactivated, non-infectious, lyophilized mycoplasma particles designed for use as an external positive control (EPC/EIC) in PCR-based mycoplasma testing.
- Compliant with EP 2.6.7 (12.2), USP <77>, and JP 18 G3
- Defined concentration of ≤100 CFU/ml, GC:CFU ratio <10
- Recommended for use as EPC/EIC

Cat. no.: 106-5001

$906.00
Tax excluded

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Resources

Manual.pdf
Compliance Information.pdf
Flyer.pdf
Data Sheet.pdf
SDS.pdf
Validation Guide
Validation Guide for 100CFU® Mycoplasma synoviae

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Product Description

Mycoplasma contamination represents one of the major risks in cell culture systems and biopharmaceutical manufacturing, including ATMPs. The European Pharmacopoeia (EP) 2.6.7, the United States Pharmacopeia (USP) <77>, and the Japanese Pharmacopoeia (JP) 18 G3 require validated test methods capable of reliably detecting both cultivable and non-cultivable mycoplasma.

100CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements and are particularly intended for use as an External Positive Control (EPC). Manufactured in accordance with EP 2.6.7 (edition 12.2), the standards are non-infectious and safe to handle. After reconstitution, defined quantities of the standard are spiked into the respective product or sample matrix to enable robust assessment of assay performance under routine conditions and to support Limit of Detection (LOD) determination.

Application-Specific Relevance

Mycoplasma synoviae is an avian-associated mycoplasma species and is particularly considered in manufacturing processes involving poultry- or egg-derived raw materials. The 100CFU® Mycoplasma synoviae standard is therefore especially relevant for processes with avian origin and supports matrix-specific assessment of potential contamination risks in corresponding production systems.

Specification

Product category 100CFU® Mycoplasma Standards
Species Mycoplasma synoviae (Mycoplasmopsis synoviae)
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10124
ATCC code 25204
Application NAT-based mycoplasma testing
Application areas External positiv control (EPC) or Extraction inhibition control (EIC)
Regulatory compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤100 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 ≤100 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

More Available Species

Cat. No. 106-1001: Mycoplasma arginini
Cat. No. 106-2001: Mycoplasma orale
Cat. No. 106-3001: Mycoplasma gallisepticum
Cat. No. 106-4001: Mycoplasma pneumoniae
Cat. No. 106-6001: Mycoplasma fermentans
Cat. No. 106-7001: Mycoplasma hyorhinis
Cat. No. 106-8001: Acholeplasma laidlawii
Cat. No. 106-9001: Spiroplasma citri
Cat. No. 106-1101: Mycoplasma salivarium