Answer Posted / ankur dwivedi

yes. It is mandatory to keep the re-processed batch for the
stability study as during the re-processing the impurity
levels can be changed and also polymorphic changes may be
possible if using other solvents. Its mentioned in GMP
practices. Nowadays it is one of the criteria from the
Regulatory Department. USFDA person can also ask for the
same. You should go through some good and standard GMP
reference books.

in dissolution if one bowl got 70 percent 2nd bowl got 80 percent and 3rd bowl got 90 percent then how proceed?

738

---

Why Ethanol is Used for Standardization of GC Head space?

4211

---

USP methodology, EP methodology, IP methodology, among three if possible to use one methodology for qualify working standard to use USP, EP, IP ? Please explain...

1996

---

Why only Copper standard is used to calibrate Atomic Absorption spectrophotometer?

2711

---

What is similarity factor?

1177

---

what is mean by extactable and leachable study?

1142

---

What is viod volume and peak purity in HPLC?

2857

---

What is diffrence between extractable volume and deliverable volume? Answer pls

4540

---

we are performed SOR for a particular product the limit is -6 to -10.We face particular bathes it is not meeting the specification.we performed diffrent instrument diffrent analyst we are getting diffrent diffrent results.solvent is dimethyl sulfoxide what could be the reasion

1849

---

What is aggregate and fragments in SEC?

2093

---

How to do regeneration of Metacarb Pb plus column?

2563

---

How to determine the EDTA content by potentiometry titration in Ceftriaxine sodium

2523

---

what is impurity profile. how to interpret this impurity profile to a drug product or drug substance.

2612

---

why digestion require in icpms?

754

---

analytical method validation require to with respect to release specification or shelf life specification?

768

---