Answer Posted / bhargav

Purity:

It is calculated by area normalisation method, it can be
directly find out by chromatograms obtained from HPLC.

% Purity = (Area of desired peak / Sum of area of all
peaks) x 100

Assay:

It is calculated against standard. It may be of following
types:

1) On as is basis = (Area of sample / Area of standard) x
(conc. of standard / conc. of sample) x potency or assay of
standard
2) On anhydrous basis = (Assay on as is basis / 100 –
moisture) x 100
3) On dried basis = (Assay on as is basis / 100 – LOD) x 100

Potency:

100 – (moisture or LOD + residual solvents + heavy metals
+ sulphated ash + impurities)

What is shaking level in GC?

799

---

How can we calculate offset value pH measurment

1519

---

pharma industries oriented

2255

---

if peak get problamatic then what require to do?

807

---

in which situation require to use paddle and basket?

744

---

UV and PDA detector, which have less signal to noise ratio?

1140

---

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

803

---

How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?

1781

---

what is definition of validation? which components are followed give detail?

2381

---

What are the primary considerations in extractables and Leachables ?

2283

---

process of Diclofenac sodium,IP.

2223

---

[3/28, 20:52] Manoj P Venkatpurwar: how many impurities require to inject in assay specificity that how we can find out? and in Rs also how?

798

---

identification is for unknown? qualification for known? reporting for LOQ?

730

---

Why to use propyl paraben in HPLC gradient calibration

7500

---

how decide the clining method and cleaning method validation require for this perticular products?

768

---