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65 Cards in this Set
- Front
- Back
what are official limits based on
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type of active ingredient contained and the accuracy of the assay method and potency
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what assay method is used for Baclofen
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HPLC
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what is the range for Baclofen
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90-110%
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what is Baclofen used for
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muscle relaxant
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what is the assay method for Bacitracin Zinc and Ploymyxin B sulfate
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microbial assay
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what is the range for Bacitracin Zinc and Ploymyxin B
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90-130%
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wha tis Bacitracin Zinc and Ploymyxin B used for
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opthalmic ointment
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what is the assay method for Bacitracin Zinc ointment or Bacitracin Opthalmc oinment
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microbial
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what is range Bacitracin Zinc or Bacitracin Opthalmic ointment
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90-140%
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what is the assay method for benoxinate HCL
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UV spectroscopy
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what is benoxinate HCL opthalmic ointment used for
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local anesthetic
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what is the range of benoxinate HCL opthalmic ointment
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95-105%
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what is the assay method for Cephalexin capsules
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HPLC
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what is the range of cephalexin capsules
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90-120%
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what is the assay method for warfarin sodium tablets
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HPLC
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what is the range of warfarin sodium tables
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95-105%
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what is the assay method for Vit A/E capsules
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HPLC
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what is the range of Vit A/E capsules
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95-120%
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what is the most accurate assay method
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HPLC
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what is a stability indicator and why
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HPLC due to it giving sperate peaks for the active drug and decomposition product
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what are the non official limits
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90-110%
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what is most important in determing limits of active ingredients in the dosage form
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assay method
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what is the assay method for L-Ascorbic acid powder
what is the indicator? |
tritration with iodine solution using start as an indicator
each ml of 0.1N I2 solution equals 8.8 mg of acid |
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what is the M.Wt. of acid in L-Ascorbic acid powder
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176
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what assay method is used in L-ascorbic acid injection
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HPLC
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what is the pH range for max stability of L-Ascorbic acid injection
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5.5-7
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why do you limit on oxalate in L-Ascorbic acid injection
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if you have too much oxalate in the injection it will precipitate out with calcium in our body
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for the monograph of L ascorbic acid oral solution what must be done
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must label the % alcohol it contains and assay it too
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what is the SP of l-ascorbic acid powder monograph
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specefic rotation done at 589 nm at 25 C
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what is the properties the of iodine solution in L-ascorbic acid powder
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it is a colored solution containing vit c as the antioxidant and therfore iodine gets reduced and loses its color (no vit c then color stays)
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what is the limit on SA in Aspirin powder
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0.1%
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what is done in the assay for Aspirin powder
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titrate with .5 NaOH
each ml equals 45.04 mg of ASA assay involves boiling the mixture of ASA + NaOH for 10 minutes and then titrate back with an acid (THIS MEANS HYDROLYSIS AND THEN REDUCTION WITH SA TO FORM NA SALT) |
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what is the purpose of NaOH and Acid in the assay of Aspirin powder
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take aspirin powder and add NaOH to hydrolyze it and consume NaOH to form Sa and HAc then titrate back with acid to neutrolize excess sodium
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what is the M.Wt. of Aspirin powder
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180.16
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what is the Eq. Wt. of Aspirin
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90.08
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what is the Eq weight of L-ascorbic acid
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88
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what assay method is used to measure ASA
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UV spectroscopy at its isobtic point and 280 nm at pH below 4
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what is the isosbestic point of ASA
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265 nm at pH above 4 and 280 nm at pH below 4
this is the wave length in which all the drug and decomposition products have the same absorption |
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what are ASA effervescent tablets for oral solution made of
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made using suitable organic acids and bicarbonate/carbonate.
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what is commonly used with Na bicarbonate
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citric and tartaric acid
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what is the solution time for 2 ASA effervescent tablets
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2 tablets in 180 mL water at 17.5 (+-2.5C) should dissolve in 5 minutes
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what is the acid neutralizing capacity of ASA effervescent talbets and what does it mean
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5 mEq of acid per tablet
this means 5 mEq of acid must be neutralized |
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what is the SA limit in ASA effervescent tablets
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8% THIS IS BECAUSE OF CO2
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what are the limits of Cefazolin Na powder
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89.1 to 110.1% on anhydrous basis
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what is the Sp. Rotation of Cefazolin Na powder
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-10 to -24 degrees
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what are the properties Cefazolin Na powder must have
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pH 4-6
100mg/mL solution water no more than 6% |
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what are the limits Cefazolin Injection
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90-115%
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what does Cefazolin Injection have to meet when you do the endotoxin test and what is the pH
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Bacterial endotoxins : not more than 0.15 USP units per mg of powder
pH 4.5-7 |
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what is the cefazolin na ophthalmic solution limit
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29.7mg to 36.3 mg per 10mL of drops
WHICH IS 90-110% |
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what is the beyond use date of ophthalmic solution
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5 days
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what is the formula given for opthalmic solution
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powder 35mg
thimerosal 0.2 mg NaCl injection(0.9%) QS to 10 mL |
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what is the pH of cefazolin Ophthamic solution
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4.5 - 6
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what is thimerosal used as
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preservative
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sterility test is performed for what
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injections and solutions and pharmaceutical compounding
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what is the nonsteril test used on
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otic
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what is the % NaCl in a injection to give isotonicity
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0.9%
isotonicity won't be irritating to the eye |
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what generation is cephalosporin
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2nd gen
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what generation is penicillin/methycillin
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1st gen
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when you need to test enteric coating what do you do
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gastric solution and intestinal solution stimulation
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what is the composition of Simulated Gastric Solution
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2 g NaCl
3.2 g pepsin 7mL HCl per liter HCl is 38% solution by weight |
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what is the pH of simulated gastric solution
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1.2
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what is the composition of simulated intestinal solution
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6.8g of KH2PO4
77 mL of 0.2N NaOH solution 10g of pancreatin per liter |
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what is the pH of the simulated intestinal solution
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6.8
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how do you adjust the simulated intestinal solution
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0.2N HCl/NaOH
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cephazolin is a what
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cephalosporin
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