A little light reading

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gsabc · #1 Post by **gsabc** » Mon Jun 09, 2008 11:24 am

The 2008 USP/NF compendium. 3553 pages in three hardbound volumes. Plus another 120 in the First Supplement. More to come in the Second Supplement. Has to weigh 20 pounds at least.

I hadn't gotten the paper version of this in a while. It's on CD-ROM, but the search program on it leaves much to be desired. It's still a bit more portable than the books. I just forgot to specify which version I wanted to our purchasing manager. Oh well.

Where to start? Lessee, "Validation of Microbial Recovery", yeah, that sounds exciting ...

Rexer25 · #2 Post by **Rexer25** » Mon Jun 09, 2008 11:43 am

To us ignert lay people, what is the 2008 USP/NF compendium?

christie1111 · #3 Post by **christie1111** » Mon Jun 09, 2008 12:09 pm

Rexer25 wrote:To us ignert lay people, what is the 2008 USP/NF compendium?

I don't know. I am just glad I don't have to read it!

MarleysGh0st · #4 Post by **MarleysGh0st** » Mon Jun 09, 2008 12:19 pm

Rexer25 wrote:To us ignert lay people, what is the 2008 USP/NF compendium?

The United States Pharmacopeia/National Formulary.

There's one available through an Amazon.com partner for a cool $999.99 (plus $3.99 shipping); better buy it now before someone else does!

gsabc · #5 Post by **gsabc** » Mon Jun 09, 2008 12:20 pm

Basically, a technical manual defining the maximum level of impurities in many drugs, chemicals and food products, and how to test for them. The USP (United States Pharmacopeia, though not a government agency) sets standards against which freshly prepared compounds are measured. Literally. They purify and sell reference standards for the drugs, etc. I don't know the current price offhand, but it used to be something like 65 milligrams for $325. The other major source of funding for the organization is sales of the books/CD's.

NF means National Formulary, which used to be a separate standard-creating organization. They merged years ago. Mostly chemicals used in food preparation, herbal concoctions, etc. If it's used to make your food, or goes into your food, chances are good it was USP or NF grade material.

The USP is the primary organization involved with standardizing drugs and drug analysis for release of product in the U.S. The main other biggies are BP in the UK (British Pharmacopeia), JP in Japan, and EP for Europe. Now there's also the ICH, an international organization (International Conference on Harmonisation) which is trying to unite all the differing standards in one big happy family. The main purpose is so drug, chemical and food companies won't have to worry about different tests and test methods.

One example of the testing that's involved: to qualify as USP grade sucrose (AKA sugar), the compound has to go through eight different tests. And that's an easy one. Water for hemodialysis purposes (admittedly a more critical item) has to be tested at least once a year for 23 different elements and compounds.

gsabc · #6 Post by **gsabc** » Mon Jun 09, 2008 12:23 pm

MarleysGh0st wrote:
Rexer25 wrote:To us ignert lay people, what is the 2008 USP/NF compendium?
The United States Pharmacopeia/National Formulary.

There's one available through an Amazon.com partner for a cool $999.99 (plus $3.99 shipping); better buy it now before someone else does!

$3.99 shipping? That's a bargain for a complete 2008 book! As I said, it must weigh 20 pounds!

They update it every few months to add more drugs and materials, and to amend the current items for improved test methods, harmonization with the rest of the world, etc. So if you're in the pharmaceutical biz, especially manufacturing, you need to keep a current version around. It's expensive, but ghu help you if you don't change your test methods to align with theirs.

MarleysGh0st · #7 Post by **MarleysGh0st** » Mon Jun 09, 2008 12:29 pm

gsabc wrote: $3.99 shipping? That's a bargain for a complete 2008 book! As I said, it must weigh 20 pounds!

Yeah, what a bargain!

But I was thinking there might be a little leeway for shipping built into that $999.99 list price...

gsabc · #8 Post by **gsabc** » Mon Jun 09, 2008 12:38 pm

MarleysGh0st wrote:
gsabc wrote: $3.99 shipping? That's a bargain for a complete 2008 book! As I said, it must weigh 20 pounds!
Yeah, what a bargain!

But I was thinking there might be a little leeway for shipping built into that $999.99 list price...

They're actually making up the shipping cost with the book price, and then some. Direct from USP, the price is $755 + $21 S/H.

I misremembered the standards pricing. The amount you get varies, depending on the compound, as does the price. Lowest price I saw in a quick peek was $185, highest was almost ten times that for 20 mg of some drug.