Question { Shilpa Medicare, 35671 }

what is the differnce between GMP and CGMP

Answer

GMP = Good Manufacturing Practices
cGMP = Current Good Manufacturing Practices. we can say
update/application of GMP practices for the current/present
year onwards.

Question { 11215 }

How we fix the validity period of a Normal solution and
re-standardization due date

Answer

Assining the Validity of the Volumetric Solution can be
done through establishing the Stability of the Normal /
Molarity of the Volumetric solution, say if the volumetric
solution is stable within ± 10% concentration of the
specified concentration. if the volumetric solution is
stable for 45 days then the validity/expiry can be assign
for 30 days and the Re-standardization date can be assign
for every 15 days.

There are no such standatd guidlines.

Question { UPL, 27705 }

Why pH range is maximum 14.0

Answer

The maximum H+ ion concentration of the solution is 10-4
can be measurable below lower value is could not be able to
measure. Hence the maximum value of the pH is 14.

Question { Cipla, 25035 }

What is (Q) point dissolution?

Answer

Single point Dissolution result of which USP/BP mention
the limits.

Ex. NLT 80%