Compendial Drug Monograph

COMPENDIAL DRUG MONOGRAPH

Objective:
1. To demonstrate comprehension on the information written on a drug
monograph.
2. To prepare a specification sheet for Vanillin, USP.

Procedure:
1. Download monograph for Vanillin, USP.
2. Prepare the specification sheet for Vanillin, USP.
3. Answer the questions found on the data sheet.

Group # 1 Member # 3 Class # 3
Name: AMBIDA, Patricia Camryne R. Section 3C-Ph

Activity 1
DRUG MONOGRAPH AND ITS COMPONENTS

VANILLIN
Specification Sheet
Test Reference Acceptance Criteria
Comparing the spectra of the sample and the
corresponding USP Reference Standard over the
range from 3800 to 650 cm^-1, the IR spectrum of
IR <197> the preparation of the sample should exhibit
maxima only at the same wavenumbers as that of
Identification the appropriately prepared corresponding USP
Reference Standard.
UV spectra of the sample solution and of the
standard solution exhibit maxima and minima at
UV <197> the same wavelengths, and, if applicable, the
absorptivities and/or absorbance ratios are within
specified limits.
Assay <857> 97.%-103.0% on the dried basis
Impurities <281> NMT 0.05%
Melting Range or
<741> 81°-83°
Temperature
Loss on Drying Dry the sample over silica gel for 4 h: it loses NMT
<731>
1.0% of its weight.

Answer the following questions:

1. What is the spectral range used in Infrared Spectroscopy?
- The spectral range used in Infrared Spectroscopy, which is related to the infrared
region of the electromagnetic spectrum is divided into three regions namely the
near-infrared (14000-4000 cm-1; 0.8-2.5 um wavelength), mid-infrared
(4000-400cm-1; 2.5-25 um) and the far-infrared (400-10 cm-1; 25-1000 um).

2. How should the sample in Infrared Spectroscopy be prepared?
- It was written in USP-NF <197K> that the sample or the substance under
examination should be mixed intimately with potassium bromide and
compressed into a transparent pellet.
3. How much sample is used for Residue on Ignition?

- Based on the USP-NF <282> to conduct the residue on ignition, 1- to 2-g of test
specimen is used.

4. Based on the procedure for Residue on Ignition, what should be done if the
amount of the residue so obtained exceeds the limit specified in the individual
monograph?
- According on the USP-NF <281> If the amount of the residue so obtained
exceeds the limit specified in the individual monograph, repeat the
moistening with sulfuric acid, heating and igniting as before, until constant
weight is attained or until the percentage of residue complies with the
limit in the individual monograph.
5. Differentiate congruent and non-congruent melting.

- Congruent melting simply indicates melting of a solid compound which is
composed of solid as well. On the other hand, incongruent melting is a phase
when melting a solid compound while decomposing. It reacts also with the
melted area to form another solid and simultaneously, can also form a liquid
that's entirely different from the original melted solid. It's basically like two states of
matter occurring while melting.

6. How much sample is used in Loss on Drying?
- Based on the USP-NF <731> to conduct the determination of Loss on Drying, 1-
to 2-g of test specimen is used.

7. How long the sample should be dried for Loss on Drying?
- According to the USP-NF <731>, the sample must be dried for 4 hours for the Loss
of Drying test.

8. How is “dry to constant weight” be performed?
- As stated by Sharma (2018), if “dry to constant weight” is mentioned, drying shall
be ongoing until two consecutive weighings do not differ by more than 0.5
milligram per gram of substance taken; The second weighing being made after
an additional hour of drying.

9. If capsules or tablets are to be used for Loss on Drying, how many of the dosage
units should be used?
- Based on the USP-NF <731>, If Capsules are to be tested, use a portion of
the mixed contents of not fewer than 4 capsules. Where Tablets are to be
tested, use powder from not fewer than 4 tablets.
-
10. If 1.0 g of the substance is dried and the final weight after drying is 850 mg, will it
pass the test for Loss on Drying? Show your computation.

It will not pass the test for loss on drying because 15% is so much higher than the
maximum allowable loss based on the monograph which is 1.0%. Therefore, it
failed the acceptance criteria.

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COMPENDIAL DRUG MONOGRAPH

3. How much sample is used for Residue on Ignition?

5. Differentiate congruent and non-congruent melting.

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