• Online only
Illustration similar or symbolic

10CFU® Mycoplasma hyorhinis

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.: 105-7001

$539.00
Tax excluded

Categories:

Related products

Help?

Do you have questions...

... about using our products?
Contact Technical Support
... about ordering our products?
Get Ordering Help
... or about our company?
Send General Inquiry

Notification of Changes

Notification of Changes

Let us notify you about our product updates.

Register here

Resources

Manual.pdf
Compliance Information.pdf
Flyer.pdf
Data Sheet.pdf
SDS.pdf
Validation Guide
Validation Guide for 10CFU® Mycoplasma hyorhinis

Please use this form to request a validation guide.

All fields are required. Please use your business contact data.

Please provide your first name. Please provide your last name. The e-mail seems to be missing or incorrect. Please provide your company/institution.
Send Validation Guide
close
cancel Unfortunately an error orcurred and the Validation Guide has not been sent.
You can try again, if the problem presists please contact us at info@minerva-biolabs.com
Try again
close
check_circle Validation Guide has been successfully sent.
Newsletter:
close
close
CoA Search

Product Description

Mycoplasma contamination represents one of the most critical 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 detecting both cultivable and non-cultivable mycoplasma.

10CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements. 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 Limit of Detection (LOD) determination and use as an External Positive Control (EPC) with a defined concentration.

Application-Specific Relevance

Mycoplasma hyorhinis is a porcine-associated mycoplasma species and is frequently reported as a contaminant in cell culture systems. The 10CFU® Mycoplasma hyorhinis standard is therefore especially suitable for matrix-specific, risk-based validation of NAT-based mycoplasma testing in processes involving porcine-derived materials as well as in human cell culture systems.

Specification

Product category 10CFU® Mycoplasma Standards
Species Mycoplasma hyorhinis (Mesomycoplasma hyorhinis)
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10130
ATCC code 17981
Application NAT-based mycoplasma testing
Application areas
  • Method validation
  • Test for Inhibitory Substances (EP 2.6.7)
  • Method Suitability Test (USP <77>)
  • External positive control
  • QC release and routine testing
Regulatory 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. 105-4001: Mycoplasma pneumoniae
Cat. No. 105-5001: Mycoplasma synoviae
Cat. No. 105-6001: Mycoplasma fermentans
Cat. No. 105-8001: Acholeplasma laidlawii
Cat. No. 105-9001: Spiroplasma citri
Cat. No. 105-1101: Mycoplasma salivarium