Download Case Study Nitrogen Determination in Polygeline and Gelatine Customer: Sanofi Aventis, Pakistan

Case Study
Nitrogen Determination in Polygeline and Gelatine
Customer: Sanofi Aventis, Pakistan
Sanofi Aventis is one of the largest and fastest growing healthcare companies in Pakistan. The
manufacturing facilities are among the most modern and environmentally friendly facilities in
the country, fulfilling the demanding standards of cGMP. More than 42 products such as oral
solids, liquid dosage forms, highly sophisticated sterile products and consumer products are
manufactured locally.
Application: Nitrogen determination in raw material
Quality testing of some critical APIs (raw materials, excipients and drug products) is performed
with BUCHI instruments. The sample is digested with sulfuric acid and a Kjeldahl Tablet using
the IR digester K- 424, followed by distillation with the KjelMaster K-375. Sanofi requires a quick,
safe, reliable and easy to use Kjeldahl system for nitrogen determination.
Equipment: Digestion Unit K-424 and KjelMaster K-375
Digestion of the samples is carried out with the help of the BUCHI IR digester K-424 in a fume
hood with a water jet pump. Nitrogen content is determined using BUCHI KjelMaster K-375
distillation unit with integrated titrator.
Benefit / Conclusion:
“BUCHI instruments allow us to perform Kjeldahl method easily with reproducible and reliable
results. We have previously used the B-339 from BUCHI, however the K-375 has many new
fascinating features which allow fast and reliable analysis with maximum productivity.”
Nudrat Adil, Manager Quality Control (Raw)
PH-129-13/06
The KjelMaster K-375 provides precise, reliable and reproducible results that fulfill the requirements of Sanofi Aventis. The total time needed for the determination of the nitrogen content in
Polygeline and Gelatine is approximately 120 minutes for each sample batch.