Answer Posted / narendra

OOS- out of specification .it means any result
not meet in specification limit or guideline limit.

Exp.-Limit 95-100 % Result obtain 110 % -OOS

OOT- Out of trend . any product batch made in single time and we analyzed time to time as per stability chart scheduled ,if stability result that is not
within the expected trend, with respect to previous/Initial
station results obtained during a stability study.
EXP.- PARACETAMOL TAB. RESULT -

Month %

0 100
6 95
12 98
24 101
36 97
48 115 - OOT

If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?

862

---

In HPLC calibration, caffeine is used as primary standard for wave length calibration due to caffeine is having dual maxima at 273 & 205 nm and one minima at 245 nm. Any body can give reference of these details from any pharmacopeia (with chapter no.) or any other authentic guideline?

2018

---

in sampling of raw material which side is pasted sampled labels

1888

---

CAN WE DETERMINE THE PEAK PURITY IN GAS CHROMATOGRAPHY ANALYSIS?

1261

---

how can give the expiry period and restadardisation of volumetric solution

2644

---

Why sodium hydroxide used for maintain pH of phosphate buffer

2486

---

in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?

890

---

how you start RS method development when for new product?

780

---

WHAT IS THE USE OF STARTER ?????????

2474

---

what is mean by dissolution hydrodynamics?

889

---

why digestion require in icpms?

830

---

which are the diffrent batches in the pharmaceuticals?

864

---

What is the diference between residual solvents and organic volatile matter

2112

---

if instrument calibration fails then what require to do?

1021

---

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

4620

---