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A liquid chromatography with high resolution mass spectrometer (LC-HRMS) was developed and validated to measure the levels of NDMA in ranitidine drug substance and drug product.

Each lot of certified kits is tested by HPLC/UV and GC/MS against 15 critical parameters. Certificate of Conformance included in every pack. Kits are delivered shrink-wrapped to ensure product cleanliness. Superior quality 1st hydrolytic class glass (Type 1) in clear and amber. Fixed insert or conical base vials for limited volume sampling.

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LC gradient conditions for Figure 1 and Figure 2.Fisher Scientific LC-MS grade water (P/N W/011217) • Fisher Scientific LC-MS grade acetonitrile (P/N A/0638/17) • Thermo Scientific ™ Pierce Trifluoroacetic acid, LC-MS Grade (P/N 28901) • Thermo Scientific National Mass Spec Certified 2 mL clear vial with blue bonded PTFE silicone cap

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About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical

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About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

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