• Online only
10CFU® Mycoplasma gallisepticum (Illustration similar or symbolic)
Illustration similar or symbolic

10CFU® Mycoplasma gallisepticum

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.: 105-3001

€429.00
Tax excluded excl. Shipping costs
This store cannot sell to USA, Canada and Mexico.
If you want your order to be delivered to these countries please visit our American store: https://minervabiolabs.us
Categories:

Related products

Do you have questions

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
SDS.pdf
Flyer.pdf
Validation Guide
10CFU® Mycoplasma gallisepticum Validation Guide for 10CFU® Mycoplasma gallisepticum

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 ocurred and the Validation Guide has not been sent.
Please, try again. If the problem persists please contact us at info@minerva-biolabs.com
Try again
close
check_circle Validation Guide has been sucesfully sent.
Newsletter:
close
close
CoA Search

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 gallisepticum is a characteristic avian mycoplasma species and is particularly associated with processes involving poultry- or egg-derived materials. The 10CFU® Mycoplasma gallisepticum standard is therefore especially suitable for matrix-specific, risk-based validation of NAT-based mycoplasma testing in manufacturing processes with avian origin.

Specification

Product category 10CFU® Mycoplasma Standards
Species Mycoplasma gallisepticum (Mycoplasmoides gallisepticum)
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10115
ATCC code 19610
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. 105-4001: Mycoplasma pneumoniae
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