QC LAB - FINALS

Dosage units

dosage forms containing a single dose or a part of a dose of drug substance in each unit.

uniformity of dosage unit

Consistency among dosage units

Weight Variation

Difference in the weight of the product

Content Uniformity

Difference in the active drug substance/s

statistical quality control (SQC)

application of statistical methods in order to improve quality control in manufacturing process.

90% - 110% USP Limit

USP limit of the weight variation of Capsules

Less than or equal to 10%

USP limit of the weight variation of tablets (Ave Weight is less than 130)

Less than or equal to 7.5%

USP limit of the weight variation of tablets (Ave Weight is 130-324)

Less than or equal to 5%

USP limit of the weight variation of tablets (Ave Weight is more than 324)

Descriptive statistics

describe quality characteristics and relationships

(i.e. mean, standard deviation, range and distribution of data.)

Statistical Process Control (SPC)

inspecting a random sample of the output from a process;

used to determine whether the process is functioning properly or not

Acceptance sampling

random inspection of a sample of products

decision is made as to whether a batch of samples should be accepted or rejected.

Central tendency

represents the average of set of values or data

Range

difference between the largest and the smallest observations in the sample

Variation

leads to quality defects and lack of product consistency.

Control charts

graphical display of a quality characteristic that has been measured or computed from a sample versus the sample number or time.

center line

represents the average value of the quality characteristic corresponding to the in-control state.

three-sigma control limits

customarily employed on control charts and on the basis that they give good results in practice.

𝟐𝟒𝟎. 𝟑𝟐 𝒎𝒈

Average Weight of Ibuprofen (PainKeller) Tablets

150.01 𝑚𝑔

Average Weight of Amoxicillin (Vacteriazide) Capsules

Beakers

Used for mixing, stirring, and heating

Erlenmeyer Flask

Allows easy mixing and swirling of the flask without too much risk of spilling

Watch Glass

container

Graduated Cylinder

To measure volume of liquids

Volumetric Flask

Used to measure an exact LARGE volume of liquid

Pipette

Measuring an exact SMALL volume of liquid and placing it into another container

Droppers

a short glass tube with a rubber bulb at one end and a tiny hole at the other, for measuring out drops of medicine or other liquids.

Burette

Used for extremely accurate addition of liquid, especially during TITRATION

Iron Stand, Ring and Clamps

Used to suspend burets, beakers, flasks, crucibles, etc. in some cases, a heat source

Aspirator (suction bulb)

A common source of CONTAMINATION

Reagent Bottles

Container for chemicals

Plastic Reagent Bottles

used empty, clean, distilled/mineral bottled water

Glass Reagent Bottles

NOT FOR ALKALIS/BASES

Titrimetric Analysis

determining the quantity of a reagent of known concentration that is required to react completely with the amount of active constituent is sample being analyzed

Standard Solution

known concentration

Analyte

substance in a sample being analyzed

Titrant

solution added from the buret

Titrand

substance being titrated

Equivalence Point

When the amount of added titrant is chemically equivalent to the amount of analyte in the sample

End point

physical change occurs that is associated with the condition of equivalence

Indicators

Added to the analyte solution to give an observable physical change.

Direct Titration

Titrant is added to analyte until a reaction goes to completion

Residual (Back) Titration

Excess reagent is added to the analyte and the excess is determined

Blank Titration

same quantities of the same reagents treated in the same manner as the solution or mixture

Normality

number of equivalents of solute per liter of solution

Standardization

To determine the exact concentration of a standard working solution

Primary Standard

highly purified compound that serves a reference material

sodium bicarbonate

Assayed with Sulfuric Acid

sodium carbonate

Primary standard to standardize Sulfuric Acid

95%-105%

USP Limit of Individual Sodium Bicarbonate

85%-115%

USP Limit of a Batch of Sodium Bicarbonate

Quantitative Transfer

Transfer of a substance from one container or vessel to another such without losing the content

Secondary Standard

Standard solution that was standardized with a primary standard

Titer

defined as the weight (usually in mg) of a substance chemically equivalent to 1 mL of the standard solution.

Milk of Magnesia (MOM)

Antacid suspension that induces Diarrhea

Magnesium hydroxide

Chemical composition of Milk of Magnesia

Precipitimetry

Based on the formation of relatively insoluble substances (precipitates) to cause the reaction to go to completion quantitatively.

Silver Nitrate

Most widely used precipitating agent/ standard solution

Argentometry

titrant used is AgNO3 standard solution

Ferric Ammonium Sulfate (ferric alum)

Indicator of argentometry

Sodium Thiosulfate

standard solution of argentometry

Reddish brown complex

Endpoint of Ferric Alum as an indicator

Adsorption Indicators

analysis of halides by direct titration w/ AgNO3 as standard solution (Weak Acid)

diffused-light condition

Endpoint of adsorption indicators

Volhard Method

form of residual or back-titration

ammonium thiocyanate

Titrant of Volhard’s Method with silver nitrate as excess

Iodized Salt

Dried, sieved, edible and iodized for human consumption

30-50 mg/kg

Iodine body requirement

50-84 mg/kg

Potassium iodate body requirement

Ligand

A molecule which provides groups for attachment to metal ions

Coordination Compounds

aka Complex

Chelate

A complex that contains two or more groups that can donate electrons

Compleximetry

Metal ion reacts with a suitable ligand to form a complex

Ethylenediaminetetraacetic acid

EDTA

hexadentate ligand

Ligand classification of EDTA

0.05 M

Common concentration of EDTA

Plaster of Paris

Calcium Sulfate Hemihydrate

Gypsum

Calcium Sulfate Dihydrate

Calcium Sulfate

odorless, white powder used as Dessicant and Building or molding material

Calcium Sulfate

Assayed with EDTA

Calcium Carbonate

Primary Standard for standardizing EDTA

Water Hardness

capacity of cations in water to form sparingly soluble products that cause “scum” in the sink or bathtub

Temporary Water Hardness

Due to presence of bicarbonates

Permanent water hardness

Due to presence of chlorides and sulfates

Permanganometry

Uses KMnO4 standard solutions

Sodium oxalate

Primary standard for Potassium Permanganate

Mineral Chameleon

Other name of Potassium Pemanganate

Oxalic acid

Sodium oxalate + H2SO4

Autocatalysis

Reactions process becomes more rapidly over time

Oxidizing agent

Type of agent of Potassium Permanganate

Reducing Agent

Type of agent of Sodium Carbonate

Agua Oxigenada

Other name for Hydrogen Peroxide

3% Hydrogen peroxide

kept in a red bottle with 10 volumes and used as an antiseptic

6% Hydrogen peroxide

kept in a blue bottle with 20 volumes and used as a bleaching agent

2.5 to 3.5%

USP limit for Hydrogen Peroxide

Reducing agent

Type of agent of Hydrogen Peroxide

weak oxidizing agent

Type of agent of Iodine

Iodine solution

Primary used for determination of strong reducing agents

Potassium iodide (KI)

added as solubilizing agent for iodine crystals

Ascorbic acid (C6H8O6 )

white to very pale yellow crystalline powder with a pleasant sharp acidic taste, almost odorless