SIRIM Berhad

Safety Assessment

 IBRC is in the synergistic relationship with the local pharmaceuticals' manufacturers that extend their trust into our laboratory. We are committed to assisting pharmaceutical companies manufacture safe modern drugs for consumers.

  • Abnormal Toxicity Test (General Test, in vivo)
  • In chemico Skin Sensitization: Direct Peptide Reactivity
  • Bacterial Endotoxin Test
  • Method validation on microbial contamination test for non-sterile dosage form
  • Microbial contamination test for non-sterile dosage form
  • Minimum inhibitory concentration
  • Sterility Test

Validation of Active Pharmaceutical Ingredients

Active pharmaceutical ingredients (API) are the central ingredient to a medicinal drug that produces its effect. API's manufacturers sell APIs like vehicles' mechanical parts to pharmaceutical companies where parts assembly is carried out until a functional product is ready for the market. Different production process and regulations between the APIs' manufacturers is resulting varying APIs' quality and strength. Validation of APIs are crucial for manufacturers seeking quality assessment to ensure the drugs' strength and quality are uncompromised.

  • Validation of active pharmaceutical ingredients

Contact Us

Tel: 03-55446960

Email: enquiryibrc@sirim.my

Address

Industrial Biotechnology Research Centre (IBRC),

Block 19,

SIRIM Berhad,

No. 1, Persiaran Dato’ Menteri,

Seksyen 2, PO BOX 7035, 40700, Shah Alam, Selangor.

Toll Free: 1-300-88-7035
General Line: 603-5544 6000
Customer Service & Support : 603- 5544 6542 /6518 / 6692/ 6693 /6762
Email: web@sirim.my
Customer Service Operating Hours:
Monday – Thursday: 8:30 am to 5:00 pm
Friday : 8:30 am to 4:45 pm 
Lunch break:
Monday – Thursday : 1.00pm  -  2.00pm
Friday :12:30pm -  2:45pm

For more details, let us hear from you.


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