insulin, tobocurarine

p. diminuta

microbal content for urethral, vaginal

lactobacillus leichmannii

ETC in stimulated intestinal fluid

totality features or conformance to specifications of a product

cobalt chloride in o/w

• Applicable for liquid products NMT 250mL • Sample size: 10 containers; 20 containers on retest • Procedure: (Angle: 30°; prevent air-bubble formation) • Single unit: drain in 5 seconds • Multiple unit: drain in ≤30 mins

oxytocin

conductivity in w/o

measure dissolution, disintegration, and bioavailability

-audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares sop

regular periodic quality reviews of al registered drug products to verify consistency of the existing process and to ientify product and process improvements

dye solubility in w/o

7

4

e. coli

conductivity in o/w

3

selecting appropriate number from the population

-identical appearance -faciliitate packaging -accuray for tablet counting machines

7/8-10kg

• For semisolids with labeled content of NMT 150g or 150ml • Sample: 10 containers (assay individually); 20 containers on retest 𝑛𝑒𝑡 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 𝑖𝑛𝑖𝑡𝑖𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 − 𝑓𝑖𝑛𝑎𝑙 𝑤𝑒𝑖𝑔ℎ𝑡 • Initial wt.: container with sample (unlabeled, cleansed, then dried) • Final wt.: empty container (heated at 100°C for 5 mins then cooled) • Acceptance Criteria: o Aerosols ▪ <60 g or 60 ml: >90% ▪ ≥ 60 g or 60 ml: > 95% o Non-aerosols ▪ Net content > labeled content

2-3 kg

5

-fastest -used at least 25g of sample

reulsive forces between particles

pliers llike

measure of flowability

part of quality assurance whic ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

6

ECT in water

quality is everybody's business

b. stearothermophilus

crude method/ sharp snap

measure of compressibility

air pump// hydraulic pressure

b. pumillus

removal of the product from themarket because it is either defective or harmful

microbial content for opthalmic

• Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution • Equipment: Vessel with cover, water bath maintained at 37±0.5 °C metallic drive shaft or Paddle.

udesired characteristic of a raw material or product which indicates that it failed to conform to rhe standards

-conducts the required tests -inspects raw materials, in process products, finished products

measure of flowability -maximum angle potential between the surface of the pile of the powder and the horizontal plane

silver diethyldithiocarbamate ts

uv flourencence in o/w

o ≥ 25mg API per dose and comprising ≥ 25% by wt. of dosage unit o Sample: 20 uncoated compressed tablets

measure of resistance to flow -should not be too fluid nor too viscous

capsule in water

cobalt chloride in w/o

>10kg

PTH

digitalis

suspended motor driven weight

barium chloride ts

mirobial content for topica dosage forms

1

b. subtilis

ammonium thiocanite ts

motor-driven anvil cushes tablet horizontally

hydrogen sulfide ts

ETC in stimulated gastric fluid

a systematic process for the assessment, control, comunication, and review of risks to the quality of the product

2

s. aureus

o Ensures formulation potency o <25 mg API per dose and comprising <25% by wt. of dosage unit o Sample: 10 units (assay individually); 20 units on retest o Acceptance Criteria: 85-115% API (100±15)

uv flourencence in w/o

lacrobacillus plantarum

micrococcus luteus

4-10 kg

buccal tablets in water

sl tablet in water

contains the detailed requirements and must be confirmed

silver nitrate ts

ideal: 100% with minimum agitation

glucagon, atropine

cod liver oil chorionic gonadotropin corticotropin vasopressin

b. subtilis med

k. pneumoniae

dye solubility in o/w

heparin, protamin sulfate

uncoated/ir tablet in water

spring