Gupta test 2
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76 terms
Terms | Definitions |
|---|---|
 more dissociate at low pH | weak base |
| more dissociated at high pH | weak acid |
| most common buffer | phosphate |
| buffer easiest on stomach | tartrate |
| slope of Arrhenius equation plot | -Ea/R |
| Ea (Arrhenius equation) | minimum energy required to start the decomposition process |
| A (Arrhenius equation) | number of collisions of the reactants per unit time |
| factors that influence K value | pH, temperature, solvent |
| stable for 3 months at 40 (+/- 2) degrees and 75% (+/-7) RH | 2 years stability at RT for marketing new dosage forms |
| 25 (+/-2) degrees and 70% RH (+/- 6) | long term stability testing |
| use estimated expiration date | only when Ea value not available |
| with each 10 degree rise | rate increase 2-5 times |
| log K vs. ionic strength increases when | both ions reacting are positive or negative |
| log K vs. ionic strength constant when | one is a molecule |
| log K vs. ionic strength decreases when | one is positive and one is negative |
| example of reversible stability reaction | tetracycline decomposing to epitetracycline |
| example of parallel/side stability reaction | corticosteroids such as hydrocortisone |
| example of consecutive/series reactions | radioactive decay (uranium to lead) |
| solid dosage form physical stability tests | weight, physical appearance, color, odor, texture |
| compressed and coated tablet physical stability tests | tablet hardness and friability |
| capsule physical stability tests | caking, clumping, drying of content |
| semi-solid (gel, cream, ointment, suppository) formulation physical stability tests | cracking, liquefaction, drying, phase separation |
| liquid and injectable formulation physical stability tests | presence of particulates, microbial contamination, pH |
| dosage form which must have every ingredient labeled | injection |
| methyldopate HCl injection | antihypertensive, catecholamine |
| buffering agent in Methyldopate HCl injection | citric acid |
| antioxidants in Methyldopate Hcl injection | monothioglycerol, sodium bisulfite |
| chelating agent in Methyldopate HCl injection | disodium EDTA |
| preservatives in methyldopate HCl injection | methylparaben, propylparaben |
| Dynacirc-CR | Isradipine, calcium antagonist, antihypertensive |
| antioxidant in Dynacirc-CR | butylated hydroxytoluene |
| polymer for CR in Dynacirc-CR | hydroxylpropyl methylcellulose |
| filler in Dynacirc-CR | PEG |
| lubricant in Dynacirc-CR | Mg stearate |
| coloring agent in Dynacirc-CR | Red and yellow Fe oxide |
| anticaking/antifoaming agent in Dynacirc-CR | silicon dioxide |
| Lustra | 4% hydroquinone USP, treatment for discoloration of skin (oral contraceptive use, HRT, skin trauma) |
| preservative in Lustra | benzyl alcohol |
| antioxidants in Lustra | ascorbyl palmitate, lecithin, sodium metabisulfite, ascorbic acid, vitamin E, butylated hydroxyanisole |
| chelating agent in Lustra | disodium EDTA |
| solvent in Lustra | water, phenyl trimethicone, glycerin alcohol, cetyl alcohol, linoleic acid, glycolic acid, glyceryl stearate, PEG100, etc |
| non-official limit of active ingredients | 90-110% |
| Baclofen tablet active ingredient limit | muscle relaxant, 90-110% by HPLC |
| Bacitracin Zinc and Ploymyxin B sulfate ophthalmic ointment active ingredient limit | 90-130% by microbial assay |
| Bacitracin Zinc ointment, Bacitracin ophthalmic ointment active ingredient limit | 90-140% by microbial assay |
| Benoxinante HCl opthalmic ointment active ingredient limit | local anesthetic, 95-105% by UV spectroscopy |
| Cephalexin capsule active ingredient limit | 90-120% by HPLC |
| warfarin sodium tablets active ingredient limit | blood thinner, 95-105% by HPLC |
| vitamin A, vitamin E capsule active ingredient limit | 95-120% by HPLC |
| L-ascorbic acid powder monograph | sp. rotation (589nm, 25C) |
| L-ascorbic acid injection monograph | pH 5.5-7.0, limit on oxalate |
| L-ascorbic acid oral solution monograph | label % alcohol |
| salicylic acid limit in aspirin powder | 0.1% |
| L-ascorbic acid powder assay | titration with iodine solution, starch as indicator |
| Each mL of 0.1N I2 solution equals | 8.8mg of acid |
| Molecular and equivalent weight of L-ascorbic acid | MW = 176, Eq. Wt. = 88 |
| aspirin powder assay | titration with 0.5N NaOH, each mL = 45.05 mg aspirin |
| Molecular and equivalent weight of ASA | MW = 180.16, Eq. Wt = 90.08 |
| ASA measurement by UV spectroscopy | at isobestic point (265nm at pH >4) and 280nm at pH <4 |
| ASA effervescent tablets for oral solution excipients | bicarbonate/carbonate; citric and tartaric acid used with Na bicarbonate |
| ASA effervescent tablets solution time | 2 tablets in 180 mL water at 17.5C in 5 minutes |
| acid neutralizing capacity of ASA effervescent tablets | 5 mEq of acid/tablet |
| SA limit of ASA effervescent tablets | 8% |
| acid neutralizing test for ASA effervescent tablets | dissolve in water, add excess of 1N HCl, titrate excess with 0.5N NaOH to stable pH of 3.5 for 10-15 seconds |
| Cefazolin Na powder limits | 89.1-110.1% on anhydrous basis |
| Cefazolin Na sp rotation | -10 - -24 degrees |
| Cefazolin Na monograph | pH 4-6, 100mg/mL, water not more than 6% |
| Cefazolin injection limits | 90-115%, pH 4.5-7 |
| Cefazolin injection bacterial endotoxins | not more than 0.15 USP units/mg of powder |
| Cefazolin ophthalmic solution limits | 29.7-36.3 mg/10 mL drops, pH 4.5-6 |
| Cefazolin ophthalmic solution formula | 35mg powder, 0.2mg Thimerosal, NaCl inj (0.9%) QS to 10mL |
| Cefazolin ophthalmic solution beyond use date | 5 days |
| gastric solution, simulated formula | 2g NaCl, 3.2g pepsin, 7mL HCl/L, pH 1.2 |
| HCl in gastric solution | 38% by weight, MW = 36.5, specific gravity = 1.3417 |
| MW NaCl | 58.5 |
| intestinal solution, simulated | 6.8g of KH2PO4 (MW = 136), 77 mL 0.2N NaOH solution, 10g pancreatin/L (pH 6.8 +/-0.1); adjust with 0.2N HCl/NaOH |
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