Module 2: Content Uniformity Test of Sodium Bicarbonate Tablets Assay of Sodium Bicarbonate

Question 1

sodium carbonate is it a primary standard or not?

Answer 1

primary standard

Question 2

sodium bicarbonate is the?

Answer 2

sample

Question 3

The STANDARD SOLUTION in Assay of Sodium bicarbonate, NaHCO3

Answer 3

0.1N H2SO4
(Acid)

Question 4

The ANALYTE in Assay of Sodium bicarbonate, NaHCO3

Answer 4

NaHCO3
(Base)

Question 5

Indicator in Assay of Sodium bicarbonate, NaHCO3

Answer 5

METHYL RED

Question 6

Assures that the strength of a therapeutic product remains “within specified acceptance limit”

Answer 6

Content Uniformity

Question 6

Known Concentration

Answer 6

STANDARD SOLUTION

Question 7

UNKNOWN
- Content/purity not yet determined

Answer 7

ANALYTE

Question 8

Used to establish within limits that a product has “uniform amounts of AI” in batch preparations of pharmaceutical dosage forms

Answer 8

Content Uniformity Test

Question 9

What are the two (2) USP specification
for sodium bicarbonate (NaHCO3)

Answer 9

(1) Individual Assay
(2) Content Uniformity By Batch

Question 10

INDIVIDUAL
Assay of Sodium Bicarbonate

USP Specification:
–Sodium bicarbonate tablets contain not less than (NLT) ___ and not more than (NMT)
____ of the labeled amount of NaHCO3

Answer 10

95% - 105%

Question 11

CONTENT UNIFORMITY
Assay of Sodium Bicarbonate

• USP Specification:
  – Amount of AI in each of the 10 dosage units lies within the range of __________ of the labeled claim.

Answer 11

85% - 115%

Question 12

based on the solute/solid (g)

Answer 12

𝒎𝑬𝒒 𝒘𝒕

Question 13

In the experiment, sodium bicarbonate is considered as
A. Analyte
B. Primary Standard
C. Standard Solution
D. Sample

Answer 13

A - Analyte

Question 13

Assay equation

Answer 13

%𝑨 =

𝒎𝑳 𝒙 𝑵 𝒙 𝒎𝑬𝒒 𝒘𝒕
————————— 𝒙 𝟏𝟎𝟎
𝒈𝒔𝒙

Question 13

in 𝒈𝒔𝒙

sx stands for

Answer 13

sample

Question 13

in %𝑨

A stands for

Answer 13

ANALYTE

Question 13

For the normality of standard sulfuric acid, use the calculated AVERAGE normality in ALL trials.

– In this case, it’s 0.09627 N H2SO4.

Answer 13

Important note

Question 14

𝒎𝑬𝒒 𝒘𝒕 formula

Answer 14

𝒎𝑬𝒒 𝒘𝒕 =

  𝑴𝑾 ----------------- 𝒇𝒆𝒒 𝒙 𝟏𝟎𝟎𝟎

Question 14

The ________ is the standard solution while the __________ is the analyte/sample.

Answer 14

1. titrant
2. titrand

Question 14

The amount of analyte, expressed as %Analyte can be calculated using the equation,

Answer 14

%𝑨 =

𝒎𝑳 𝒙 𝑵 𝒙 𝒎𝑬𝒒 𝒘𝒕
————————— 𝒙 𝟏𝟎𝟎
𝒈𝒔𝒙

Question 14

In Assay,

the _____________ of analyte in a sample is determined based on the volume of standard solution reacted with the analyte

Answer 14

amount/content