Qc Lecture Powerpownt

INTRODUCTION TO QUALITY CONTROL The term “quality” as applied to a drug product has been defined as the sum of all factors which contribute directly or indirectly to the safety,, effectiveness, and reliability of the product . These properties safety are built into drug products through research and during the manufacturing process by procedures collectively referred to as “quality control.” Quality Control guarantees within reasonable limits that a drug drug product: (1) is free of impurities (2) is physically and chemically stable (3) contains the amount of active ingredient as stated on the label, and (4) provides optimal release of active ingredients when the product is administered.

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Four Classes of Reagents in the Laboratory 1.

Technical or Commercial Grade – the cheapest kind. They have not been purified very well and can’t be used for quantitative work.

2.

USP Grade – these have been purified to conform with w ith the standards set by the USP book. They are used in compounding medicines and dispensing prescription in drugstores.

3.

Chemically Pure or CP grade – these have undergone a very thorough purification. The quantity of impurity is very small. This can be used for quantitative work.

4.

Analytical Reagent or AR grade – the most expensive class of









Types of Solution Based on Concentration 1. Concentrated Solution – a solution containing a relative large amount of solute. Examples:

Pure HCl – 37% pure & 12N CP H2SO4 H2SO4 - 98% pure & 36N Conc. HNO3 – 65% pure & 16N Conc. NH4OH – 28% pure & 14N

2. Dilute Solution – a solution containing a small amount of solute 3. Saturated Solution – a solution containing the maximum amount of solute that the solvent can dissolve. 4. Unsaturated solution – a solution containing less solute that









Ways of Expressing Strength of Solution 1. Weight/unit Volume – expresses the weight w eight of solute in grams per ml of solution. Ex. 2 grams BaCl2 / ml 2. Specific gravity – this is used for alcoholic solution which is numerically equal to density. Density = specific gravity D = w/v; w /v; specific gravity = weight/ volume Examples: a) What is the weight in grams of 10 ml H2SO4 whose sp. gr. is 1.84? 10ml g H2SO4 = 18.4 g H2SO4 b) What is the volume in ml of 12 grams HCl whose w hose sp gr is 1.15? 12 g HCl = 10.43 ml HCl 3. Ratio – proportional amount or parts of solute compared to the proportional amount or part of solvent









Examples: 1. What is the the % streng strength th of a ½ liter liter NaCl soluti solution on contain containing ing 8 grams of solute? 2. How many many ml of of a 2% Iodi Iodine ne solut solution ion can can be prep prepare ared d out of 22 grams iodine crystal? 3. How many many grams grams of of silve silverr nitrat nitrate e will you you need need to prep prepare are 1 liter of a 5% silver nitrate solution?

5. Molar solution – a solution containing one gram molecular weight of solute in one liter of solution. Examples: 1. If 28 gram grams s of KOH KOH are diss dissol olved ved in q.s. q.s. water water to make make a









6. Normal solution – a solution containing one gram equivalent weight of solute in liter of solution. GEW

=molecular weight - no. of replaceable H+ in acidic compounds - no. of replaceable replaceable OH- in basic compounds - total + valence valence in neutral salts salts OR - no. of electrons gained or lost in REDOX

Determination of milliequivalent milliequivalent weight (meq wt) Meq wt = 1/1000 of an equivalent weight OR Meq wt = Eq wt wt//1000 OR Meq wt =molecular weight - total no. of + valence











Examples: SALTS NaCl Na2SO4 CaCl2 AlCl3

ACIDS

BASES

HCl H2SO4 H3PO4 CH3COOH

KOH Ba(OH)2 Al(OH)3 Mg(OH)2











STOICHIOMETRY INVOLVING NORMALITIES N=

Weight of substance Volume in ml x meq wt











Methods of Analysis in Quantitative Quantitative Pharmaceutical Pharmaceutical Chemistry may be divided according to the following followi ng procedures: follow ing I.

General Methods used in official Pharmaceutica Pharmaceuticall Analyses:

1. Volumetric (Titrimetric) Methods – is the determination of the volume of a solution of known concentration required required to react with a given











NEUTRALIZATION METHODS : Indicators used in Neutralization Method: INDICATORS

ACID

ALKALINE

Ph

C l l

D k i k/

l hth l i

NEUTRAL d Li ht i k











Rules governing the use of Indicators:

a.

Unle Un less ss oth other erwise wise sp spec ecif ifie ied, d, us use e onl only y 2 dr drop ops s of of ind indic icat ator or

b.

In th the e titra titrati tion on of st stro rong ng ba base se wit with h str stron ong g acid acid an any y of of the the three (3) indicators may be used.













STEPS INVOLVED IN VOLUMETRIC











STEPS INVOLVED IN VOLUMETRIC ANALYSIS











B. COMPARISON – after a pair of solutions have been prepared, their concentrations are then compared with each other. Their relative concentration are expressed in terms of the ratio of concentration.





















2. Use of the ratio





















































Qc Lecture Powerpownt

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